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titleTobacco 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 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 foundThe following example illustrates the representation of a smokeless tobacco product's (portioned snus) identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

Rows 1-3:
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Rows 1-4:Show the records for a device given SPTOBID of the
Show the tobacco product is a Electronic Nicotine Delivery Systems (ENDS) Vape closed e-cigarette.
Rows 5-8:Show the package type is a Box that contains 1 E-Cigarettes that is 107.2 mm long and 9.0 mm in diameter.
Rows 9-12:Show the attributes or characteristics of the content of the e-liquid within the E-cigarette.
Rows 13-15:Show the attributes or characteristics of the heating element for the E-cigarette .
Dataset2
13
RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOPARMCDTOTESTTOPARMTOCATTOORRESTOSCATTOORRESUTOVALTOSTRESCTOVALUTOSTRESNTOSTRESU
1

TOB17

TOSNUS-771TBPRDCATTobacco Product CategoryNEW PRODUCTPRODUCT IDENTIFIERSmokeless Tobacco ProductSmokeless Tobacco ProductProducts
2TOB17TOSNUS-772TBPRSCATTobacco Product SubcategoryNEW PRODUCTPRODUCT IDENTIFIERPortioned Snus, portionedSnus, portioned
3TOB17TOSNUS-773MANUFManufacturerNEW PRODUCTPRODUCT IDENTIFIERJoes SmokelessJoes Smokeless
4TOB17TOSNUS-774TRADENAMTrade NameNEW PRODUCTPRODUCT IDENTIFIERHappy Dog SnusHappy Dog Snus
5TOB17TOSNUS-775PACKTYPPackage TypeNEW PRODUCTPRODUCT DESCRIPTORPlastic can and plastic lidPlastic can and plastic lidCan with Lid
6TOB17TOSNUS-776PACKQUANPackage QuantityNEW PRODUCTPRODUCT DESCRIPTOR24g
7TOB17TOSNUS-777PRTMASSPortion MassNEW PRODUCTPRODUCT DESCRIPTOR1g
8TOB17TOSNUS-778PORTCONTPortion countNEW PRODUCTPRODUCT DESCRIPTOR24eaches or blank?
9TOB17TOSNUS-779PRTLENGPortion lengthNEW PRODUCTPRODUCT DESCRIPTOR30mm
10TOB17TOSNUS-7710PRTWDTHPortion widthNEW PRODUCTPRODUCT DESCRIPTOR10mm
11TOB17TOSNUS-7711PRTTHICKPortion thicknessNEW PRODUCTPRODUCT DESCRIPTOR5mm
12TOB17TOSNUS-7712CHARFLAVCharacterizing FlavorMintNEW PRODUCTPRODUCT DESCRIPTORTOB17TOSNUS-7713Additional propertyn/a

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.

Flavored

The manufacturing parameter specifications of the portioned snus tobacco product as intended for use are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 10 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally. 

Show the design parameter specification with the test condition of 20 degrees Celsius using the DPTSTCND variable.
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Namepd
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Namedp
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Rows 1-94:Show the design parameter specification with target, minimum, and maximum value reflected in the DPCOLSRT variable.
Rows 80-82:
Dataset2
RowSTUDYIDDOMAINSPTOBIDDPSEQPDSEQDPTESTCDPDPARMCDDPTESTPDPARMDPTSTCNDPDVALTRGDPCATPDVALMINDPSCATPDVALMAXDPORRESDPORRESUDPSTRESCDPSTRESNDPSTRESUDPCOLSRTPDVALU
1

TOB17

DPPDSNUS-77

1

TOCUTSIZTobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inch

70

65

75

cuts/in

TARGET

2

TOB17

DPPDSNUS-77

1

2TOPRTSIZTobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inchMINIMUM3TOB17DPSNUS-773Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATIONmm or cuts per inchMAXIMUM

70

65

75

mm

3TOB17PD4TOB17DPSNUS-774Tobacco MoistureDESIGN PARAMETER SPECIFICATION%TARGET5TOB17DPSNUS-775Tobacco MoistureDESIGN PARAMETER SPECIFICATION%MINIMUM6TOB17DPSNUS-776Tobacco MoistureDESIGN PARAMETER SPECIFICATION%MAXIMUM2TOMOISTRTobacco Moisture32.23134%
4TOB17PD7TOB17DPSNUS-7773Portion LengthDESIGN PARAMETER SPECIFICATIONmmTARGET8TOB17DPSNUS-778PRTLENGPortion LengthDESIGN PARAMETER SPECIFICATIONmmMINIMUM9TOB17DPSNUS-779Portion LengthDESIGN PARAMETER SPECIFICATION3836.539.5mm
5TOB17PDmmMAXIMUM10TOB17DPSNUS-7710Portion WidthDESIGN PARAMETER SPECIFICATIONmmTARGET11TOB17DPSNUS-77114PRTWDTHPortion WidthDESIGN PARAMETER SPECIFICATION16mmMINIMUM12TOB17DPSNUS-7712Portion WidthDESIGN PARAMETER SPECIFICATIONmm1517mm
6MAXIMUM13TOB17DPPDSNUS-7713Portion MassDESIGN PARAMETER SPECIFICATIONmgTARGET14TOB17DPSNUS-77145PRTMASSPortion MassDESIGN PARAMETER SPECIFICATION1000mg900MINIMUM15TOB17DPSNUS-7715Portion MassDESIGN PARAMETER SPECIFICATIONmgMAXIMUMMINIMUM1100mg
716TOB17DPPDSNUS-7716Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATIONmmTARGETMAXIMUM17TOB17DPSNUS-7717Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATIONmmMINIMUMTARGET18TOB17DPSNUS-7718Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATIONmmMAXIMUMMINIMUM6PRTTHICKPortion Material Thickness0.060.0550.065mm
8TOB17PD19TOB17DPSNUS-7719Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATIONg/m^2TARGETMAXIMUM20TOB17DPSNUS-7720Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATIONg/m^2MINIMUMTARGET21TOB17DPSNUS-7721Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATIONg/m^2MAXIMUMMINIMUM7PRTMWGTPouch Material Basis Weight161517g/m2
9TOB17PD22TOB17DPSNUS-7722Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or L/m^2/sTARGETMAXIMUM23TOB17DPSNUS-7723Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or L/m^2/sMINIMUMTARGET24TOB17DPSNUS-7724Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATIONCORESTA Unit (Cu) or L/m^2/sMAXIMUMMINIMUM8PRTMPORPouch Material Porosity185016002200L/m2/s
10TOB17PD25TOB17DPSNUS-7725Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION%/minTARGETMAXIMUM26TOB17DPSNUS-7726Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION%/minMINIMUMTARGET27TOB17DPSNUS-7727Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION%/minMAXIMUMMINIMUM9NICTDSRTNicotine Dissolution Rate15522%/min

Finally, the PT domain is used to represent the actual results of testing the manufactured portioned snus product for conformance to the tobacco product design parameters shown in PD. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. 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 rowsThe 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).

Shows the design parameter specification test condition of 20 degrees Celsius using the TTTSTCND variable for the E-Liquid Viscosity test.
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Rows 1-32:Show the tobacco design parameter specification test and the result in ORRES (needs populated).
Row 28:
pt
Dataset2
TTSTRESU
RowSTUDYIDDOMAINSPTOBIDTTSEQPTSEQTTREFIDPTTESTCDTTTESTCDPTTESTTTTESTPTCATTTTSTCNDPTORRESTTCATPTORRESUTTSCATPTSTRESCTTORRESPTSTRESNTTORRESUTTSTRESCTTSTRESNPTSTRESUPTREPNUM
1TOB17TTPTSNUS-771TOCUTSIZTobacco Cut SizeDESIGN PARAMETER TESTING

70

cuts per inch

70

70

cuts/in1
2TOB17PTSNUS-771TOPRTSIZ or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION TEST RESULTmm or cuts per inchTESTING

70

mm

70

70

mm1
32TOB17TTPTSNUS-772TOMOISTRTobacco MoistureDESIGN PARAMETER SPECIFICATION TEST RESULT%TESTING31.8%31.831.8%1
43TOB17TTPTSNUS-773PRTMASSPortion MassDESIGN PARAMETER SPECIFICATION TEST RESULTTESTING998mg998998mg1
54TOB17TTPTSNUS-774Pouch material basis weightDESIGN PARAMETER SPECIFICATION TEST RESULTg/m^25PRTMWGTPouch Material Basis WeightDESIGN PARAMETER TESTING15.3g/m215.315.3g/m21
6TOB17PTTOB17TTSNUS-775Pouch material porosity (permeability)DESIGN PARAMETER SPECIFICATION TEST RESULTCORESTA Unit (Cu) or L/m^2/sPRTMPORPouch Material PorosityDESIGN PARAMETER TESTING1900L/m2/s19001900L/m2/s1
7TOB17PT6TOB17TTSNUS-776NICTDSRTNicotine dissolution rateDissolution RateDESIGN PARAMETER SPECIFICATION TEST RESULTTESTING18%/min1818%/min1