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Tobacco 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 found.


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.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOTESTCDTOTESTTOCATTOORRESTOORRESUTOSTRESCTOSTRESNTOSTRESU
1

TOB17

TOSNUS-771TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERSmokeless Tobacco Product
Smokeless Tobacco Product

2TOB17TOSNUS-772TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERSnus, portioned
Snus, portioned

3TOB17TOSNUS-773MANUFManufacturerPRODUCT IDENTIFIERJoes Smokeless
Joes Smokeless

4TOB17TOSNUS-774TRADENAMTrade NamePRODUCT IDENTIFIERHappy Dog Snus
Happy Dog Snus

5TOB17TOSNUS-775PACKTYPPackage TypePRODUCT DESCRIPTORPlastic can and plastic lid
Plastic can and plastic lid

6TOB17TOSNUS-776
Package QuantityPRODUCT DESCRIPTOR24g


7TOB17TOSNUS-777
Portion MassPRODUCT DESCRIPTOR1g


8TOB17TOSNUS-778
Portion countPRODUCT DESCRIPTOR24eaches or blank? - EACH?


9TOB17TOSNUS-779
Portion lengthPRODUCT DESCRIPTOR30mm


10TOB17TOSNUS-7710
Portion widthPRODUCT DESCRIPTOR10mm


11TOB17TOSNUS-7711
Portion thickness
5mm


12TOB17TOSNUS-7712
Characterizing Flavor
Mint



13TOB17TOSNUS-7713
Additional property
n/a



$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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.

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.

dp.xpt

dp.xpt

RowSTUDYIDDOMAINSPTOBIDDPSEQDPTESTCDDPTESTDPTSTCNDDPCATDPSCATDPORRESDPORRESUDPSTRESCDPSTRESNDPSTRESUDPCOLSRT
1

TOB17

DPSNUS-771
Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION
mm or cuts per inch




TARGET
2TOB17DPSNUS-772
Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION
mm or cuts per inch




MINIMUM
3TOB17DPSNUS-773
Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION
mm or cuts per inch




MAXIMUM
4TOB17DPSNUS-774
Tobacco MoistureDESIGN PARAMETER SPECIFICATION
%




TARGET
5TOB17DPSNUS-775
Tobacco MoistureDESIGN PARAMETER SPECIFICATION
%




MINIMUM
6TOB17DPSNUS-776
Tobacco MoistureDESIGN PARAMETER SPECIFICATION
%




MAXIMUM
7TOB17DPSNUS-777
Portion LengthDESIGN PARAMETER SPECIFICATION
mm




TARGET
8TOB17DPSNUS-778
Portion LengthDESIGN PARAMETER SPECIFICATION
mm




MINIMUM
9TOB17DPSNUS-779
Portion LengthDESIGN PARAMETER SPECIFICATION
mm




MAXIMUM
10TOB17DPSNUS-7710
Portion WidthDESIGN PARAMETER SPECIFICATION
mm




TARGET
11TOB17DPSNUS-7711
Portion WidthDESIGN PARAMETER SPECIFICATION
mm




MINIMUM
12TOB17DPSNUS-7712
Portion WidthDESIGN PARAMETER SPECIFICATION
mm




MAXIMUM
13TOB17DPSNUS-7713
Portion MassDESIGN PARAMETER SPECIFICATION
mg




TARGET
14TOB17DPSNUS-7714
Portion MassDESIGN PARAMETER SPECIFICATION
mg




MINIMUM
15TOB17DPSNUS-7715
Portion MassDESIGN PARAMETER SPECIFICATION
mg




MAXIMUM
16TOB17DPSNUS-7716
Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATION
mm




TARGET
17TOB17DPSNUS-7717
Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATION
mm




MINIMUM
18TOB17DPSNUS-7718
Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATION
mm




MAXIMUM
19TOB17DPSNUS-7719
Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATION
g/m^2




TARGET
20TOB17DPSNUS-7720
Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATION
g/m^2




MINIMUM
21TOB17DPSNUS-7721
Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATION
g/m^2




MAXIMUM
22TOB17DPSNUS-7722
Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or L/m^2/s




TARGET
23TOB17DPSNUS-7723
Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or L/m^2/s




MINIMUM
24TOB17DPSNUS-7724
Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATION
CORESTA Unit (Cu) or L/m^2/s




MAXIMUM
25TOB17DPSNUS-7725
Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION
%/min




TARGET
26TOB17DPSNUS-7726
Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION
%/min




MINIMUM
27TOB17DPSNUS-7727
Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION
%/min




MAXIMUM
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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).

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.

tt.xpt

tt.xpt

RowSTUDYIDDOMAINSPTOBIDTTSEQTTREFIDTTTESTCDTTTESTTTTSTCNDTTCATTTSCATTTORRESTTORRESUTTSTRESCTTSTRESNTTSTRESU
1TOB17TTSNUS-771

Tobacco Cut Size or Tobacco Particle Size
DESIGN PARAMETER SPECIFICATION TEST RESULT

mm or cuts per inch


2TOB17TTSNUS-772

Tobacco Moisture
DESIGN PARAMETER SPECIFICATION TEST RESULT

%


3TOB17TTSNUS-773

Portion Mass
DESIGN PARAMETER SPECIFICATION TEST RESULT

mg


4TOB17TTSNUS-774

Pouch material basis weight
DESIGN PARAMETER SPECIFICATION TEST RESULT

g/m^2


5TOB17TTSNUS-775

Pouch material porosity (permeability)
DESIGN PARAMETER SPECIFICATION TEST RESULT

CORESTA Unit (Cu) or L/m^2/s


6TOB17TTSNUS-776

Nicotine dissolution rate
DESIGN PARAMETER SPECIFICATION TEST RESULT

%/min


$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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