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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 characterization, property description, and design parameter information in an FDA marketing application for one type of tobacco product SNUS. 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 product Premarket Authorization (PMTA) and Substantial Equivalence pathways. The applicant submitting for SE and PMTAs may include test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.
Tobacco Product Identifier (TO) (similar to Device Identifiers (DI)) is a study reference dataset that provides a mechanism for uniquely identifying a device (tobacco) product. 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), such as device (product category) type, manufacturer, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Device Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the device (product) may be found.
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| Rows 1-4: | Show the records for a device given SPTOBID of the Smokeless Tobacco Product, portioned SNUS.
| | Rows 1-3: | Show the tobacco product is Joes Smokeless, Happy Dog Snus. | | Rows 5-11: | Show the package type is a Plastic Can and Plastic Lid that is a package of 24 with a portion mass of 1g each. in 30 mm x 10 mm x 5 mm cans.
| | Rows 12-13: | Show the attributes or characteristics of the content of the SNUS. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU |
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| 1 | | TO | SNUS-77 | 1 | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | Smokeless Tobacco Product |
| Smokeless Tobacco Product |
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| | 2 | TOB17 | TO | SNUS-77 | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Snus, portioned |
| Snus, portioned |
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| | 3 | TOB17 | TO | SNUS-77 | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | Joes Smokeless |
| Joes Smokeless |
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| | 4 | TOB17 | TO | SNUS-77 | 4 | TRADENAM | Trade Name | PRODUCT IDENTIFIER | Happy Dog Snus |
| Happy Dog Snus |
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| | 5 | TOB17 | TO | SNUS-77 | 5 | PACKTYP | Package Type | PRODUCT DESCRIPTOR | Plastic can and plastic lid |
| Plastic can and plastic lid |
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| | 6 | TOB17 | TO | SNUS-77 | 6 |
| Package Quantity | PRODUCT DESCRIPTOR | 24 | g |
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| | 7 | TOB17 | TO | SNUS-77 | 7 |
| Portion Mass | PRODUCT DESCRIPTOR | 1 | g |
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| | 8 | TOB17 | TO | SNUS-77 | 8 |
| Portion count | PRODUCT DESCRIPTOR | 24 | eaches or blank? - EACH? |
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| | 9 | TOB17 | TO | SNUS-77 | 9 |
| Portion length | PRODUCT DESCRIPTOR | 30 | mm |
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| | 10 | TOB17 | TO | SNUS-77 | 10 |
| Portion width | PRODUCT DESCRIPTOR | 10 | mm |
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| | 11 | TOB17 | TO | SNUS-77 | 11 |
| Portion thickness |
| 5 | mm |
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| | 12 | TOB17 | TO | SNUS-77 | 12 |
| Characterizing Flavor |
| Mint |
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| | 13 | TOB17 | TO | SNUS-77 | 13 |
| Additional property |
| n/a |
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The Tobacco Design Parameters (DP) is similar to the Device Properties (DO) domain represents properties of the tobacco product that do not vary over the life of the product. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TPTESTCD/TPTEST.
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| Rows 1-27: | Show the design parameter specification with target, minimum, and maximum value reflected in the DPCOLSRT variable. | | Rows 7-18: | Show the design parameter specification for portioned characteristics. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | DPSEQ | DPTESTCD | DPTEST | DPTSTCND | DPCAT | DPSCAT | DPORRES | DPORRESU | DPSTRESC | DPSTRESN | DPSTRESU | DPCOLSRT |
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| 1 | | DP | SNUS-77 | 1 |
| Tobacco Cut Size or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION |
| mm or cuts per inch |
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| TARGET | | 2 | TOB17 | DP | SNUS-77 | 2 |
| Tobacco Cut Size or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION |
| mm or cuts per inch |
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| MINIMUM | | 3 | TOB17 | DP | SNUS-77 | 3 |
| Tobacco Cut Size or Tobacco Particle Size | DESIGN PARAMETER SPECIFICATION |
| mm or cuts per inch |
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| MAXIMUM | | 4 | TOB17 | DP | SNUS-77 | 4 |
| Tobacco Moisture | DESIGN PARAMETER SPECIFICATION |
| % |
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| TARGET | | 5 | TOB17 | DP | SNUS-77 | 5 |
| Tobacco Moisture | DESIGN PARAMETER SPECIFICATION |
| % |
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| MINIMUM | | 6 | TOB17 | DP | SNUS-77 | 6 |
| Tobacco Moisture | DESIGN PARAMETER SPECIFICATION |
| % |
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| MAXIMUM | | 7 | TOB17 | DP | SNUS-77 | 7 |
| Portion Length | DESIGN PARAMETER SPECIFICATION |
| mm |
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| TARGET | | 8 | TOB17 | DP | SNUS-77 | 8 |
| Portion Length | DESIGN PARAMETER SPECIFICATION |
| mm |
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| MINIMUM | | 9 | TOB17 | DP | SNUS-77 | 9 |
| Portion Length | DESIGN PARAMETER SPECIFICATION |
| mm |
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| MAXIMUM | | 10 | TOB17 | DP | SNUS-77 | 10 |
| Portion Width | DESIGN PARAMETER SPECIFICATION |
| mm |
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| TARGET | | 11 | TOB17 | DP | SNUS-77 | 11 |
| Portion Width | DESIGN PARAMETER SPECIFICATION |
| mm |
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| MINIMUM | | 12 | TOB17 | DP | SNUS-77 | 12 |
| Portion Width | DESIGN PARAMETER SPECIFICATION |
| mm |
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| MAXIMUM | | 13 | TOB17 | DP | SNUS-77 | 13 |
| Portion Mass | DESIGN PARAMETER SPECIFICATION |
| mg |
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| TARGET | | 14 | TOB17 | DP | SNUS-77 | 14 |
| Portion Mass | DESIGN PARAMETER SPECIFICATION |
| mg |
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| MINIMUM | | 15 | TOB17 | DP | SNUS-77 | 15 |
| Portion Mass | DESIGN PARAMETER SPECIFICATION |
| mg |
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| MAXIMUM | | 16 | TOB17 | DP | SNUS-77 | 16 |
| Portion (pouch) material thickness (if applicable) | DESIGN PARAMETER SPECIFICATION |
| mm |
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| TARGET | | 17 | TOB17 | DP | SNUS-77 | 17 |
| Portion (pouch) material thickness (if applicable) | DESIGN PARAMETER SPECIFICATION |
| mm |
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| MINIMUM | | 18 | TOB17 | DP | SNUS-77 | 18 |
| Portion (pouch) material thickness (if applicable) | DESIGN PARAMETER SPECIFICATION |
| mm |
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| MAXIMUM | | 19 | TOB17 | DP | SNUS-77 | 19 |
| Pouch material basis weight (if applicable) | DESIGN PARAMETER SPECIFICATION |
| g/m^2 |
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| TARGET | | 20 | TOB17 | DP | SNUS-77 | 20 |
| Pouch material basis weight (if applicable) | DESIGN PARAMETER SPECIFICATION |
| g/m^2 |
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| MINIMUM | | 21 | TOB17 | DP | SNUS-77 | 21 |
| Pouch material basis weight (if applicable) | DESIGN PARAMETER SPECIFICATION |
| g/m^2 |
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| MAXIMUM | | 22 | TOB17 | DP | SNUS-77 | 22 |
| Pouch material porosity (permeability) (if applicable) | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) or L/m^2/s |
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| TARGET | | 23 | TOB17 | DP | SNUS-77 | 23 |
| Pouch material porosity (permeability) (if applicable) | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) or L/m^2/s |
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| MINIMUM | | 24 | TOB17 | DP | SNUS-77 | 24 |
| Pouch material porosity (permeability) (if applicable) | DESIGN PARAMETER SPECIFICATION |
| CORESTA Unit (Cu) or L/m^2/s |
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| MAXIMUM | | 25 | TOB17 | DP | SNUS-77 | 25 |
| Nicotine dissolution rate | DESIGN PARAMETER SPECIFICATION |
| %/min |
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| TARGET | | 26 | TOB17 | DP | SNUS-77 | 26 |
| Nicotine dissolution rate | DESIGN PARAMETER SPECIFICATION |
| %/min |
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| MINIMUM | | 27 | TOB17 | DP | SNUS-77 | 27 |
| Nicotine dissolution rate | DESIGN PARAMETER SPECIFICATION |
| %/min |
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| MAXIMUM |
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The Tobacco Product Testing (TT) (similar to the Laboratory Test Results (LB) domain) dataset shows the tobacco product test demonstrating the actual tests and test results for the specified Design Parameter Specification as noted in the DU dataset (??? DP dataset).
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| Rows 1-6: | Show the tobacco design parameter specification test and the result in ORRES for the SNUS. (needs populated).
| | Row 3: | Shows the design parameter specification for the portion mass.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | TTSEQ | TTREFID | TTTESTCD | TTTEST | TTTSTCND | TTCAT | TTSCAT | TTORRES | TTORRESU | TTSTRESC | TTSTRESN | TTSTRESU |
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| 1 | TOB17 | TT | SNUS-77 | 1 |
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| Tobacco Cut Size or Tobacco Particle Size |
| DESIGN PARAMETER SPECIFICATION TEST RESULT |
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| mm or cuts per inch |
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| | 2 | TOB17 | TT | SNUS-77 | 2 |
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| Tobacco Moisture |
| DESIGN PARAMETER SPECIFICATION TEST RESULT |
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| % |
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| | 3 | TOB17 | TT | SNUS-77 | 3 |
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| Portion Mass |
| DESIGN PARAMETER SPECIFICATION TEST RESULT |
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| mg |
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| | 4 | TOB17 | TT | SNUS-77 | 4 |
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| Pouch material basis weight |
| DESIGN PARAMETER SPECIFICATION TEST RESULT |
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| g/m^2 |
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| | 5 | TOB17 | TT | SNUS-77 | 5 |
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| Pouch material porosity (permeability) |
| DESIGN PARAMETER SPECIFICATION TEST RESULT |
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| CORESTA Unit (Cu) or L/m^2/s |
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| | 6 | TOB17 | TT | SNUS-77 | 6 |
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| Nicotine dissolution rate |
| DESIGN PARAMETER SPECIFICATION TEST RESULT |
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| %/min |
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