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Tobacco domains

DI = TO for Tobacco Product Identifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = Tobacco Product Design Parameters (PD)

LB = Tobacco Product Testing (PT) - [Would Findings be better?]

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 tobacco product. 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, properties, product name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID), a consistent variable, that is available for use in other domains where data pertaining to the product may be found.


Rows 1-4:Show the records for a tobacco product 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 (PD) 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 PDCOLSRT variable.
Rows 7-18:Show the design parameter specification for portioned characteristics.

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDTESTCDPDTESTPDTSTCNDPDCATPDSCATPDORRESPDORRESUPDSTRESCPDSTRESNPDSTRESUPDCOLSRT
1

TOB17

PDSNUS-771
Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION

70

mm or cuts per inch

70

70

mm or cuts per inch

TARGET
2TOB17PDSNUS-772
Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION

65mm or cuts per inch6565mm or cuts per inchMINIMUM
3TOB17PDSNUS-773
Tobacco Cut Size or Tobacco Particle SizeDESIGN PARAMETER SPECIFICATION

75mm or cuts per inch7575mm or cuts per inchMAXIMUM
4TOB17PDSNUS-774
Tobacco MoistureDESIGN PARAMETER SPECIFICATION

32.2%32.232.2%TARGET
5TOB17PDSNUS-775
Tobacco MoistureDESIGN PARAMETER SPECIFICATION

31%3131%MINIMUM
6TOB17PDSNUS-776
Tobacco MoistureDESIGN PARAMETER SPECIFICATION

34%3434%MAXIMUM
7TOB17PDSNUS-777
Portion LengthDESIGN PARAMETER SPECIFICATION

38mm3838mmTARGET
8TOB17PDSNUS-778
Portion LengthDESIGN PARAMETER SPECIFICATION

36.5mm36.536.5mmMINIMUM
9TOB17PDSNUS-779
Portion LengthDESIGN PARAMETER SPECIFICATION

39.5mm39.539.5mmMAXIMUM
10TOB17PDSNUS-7710
Portion WidthDESIGN PARAMETER SPECIFICATION

16mm1616mmTARGET
11TOB17PDSNUS-7711
Portion WidthDESIGN PARAMETER SPECIFICATION

15mm1515mmMINIMUM
12TOB17PDSNUS-7712
Portion WidthDESIGN PARAMETER SPECIFICATION

17mm1717mmMAXIMUM
13TOB17PDSNUS-7713
Portion MassDESIGN PARAMETER SPECIFICATION

1000mg10001000mgTARGET
14TOB17PDSNUS-7714
Portion MassDESIGN PARAMETER SPECIFICATION

900mg900900mgMINIMUM
15TOB17PDSNUS-7715
Portion MassDESIGN PARAMETER SPECIFICATION

1100mg11001100mgMAXIMUM
16TOB17PDSNUS-7716
Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATION

0.06mm0.060.06mmTARGET
17TOB17PDSNUS-7717
Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATION

0.055mm0.0550.055mmMINIMUM
18TOB17PDSNUS-7718
Portion (pouch) material thickness (if applicable)DESIGN PARAMETER SPECIFICATION

0.065mm0.0650.065mmMAXIMUM
19TOB17PDSNUS-7719
Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATION

16g/m^21616g/m^2TARGET
20TOB17PDSNUS-7720
Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATION

15g/m^21515g/m^2MINIMUM
21TOB17PDSNUS-7721
Pouch material basis weight (if applicable)DESIGN PARAMETER SPECIFICATION

17g/m^21717g/m^2MAXIMUM
22TOB17PDSNUS-7722
Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATION

1850L/m^2/s18501850L/m^2/sTARGET
23TOB17PDSNUS-7723
Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATION

1600L/m^2/s16001600L/m^2/sMINIMUM
24TOB17PDSNUS-7724
Pouch material porosity (permeability) (if applicable)DESIGN PARAMETER SPECIFICATION

2200L/m^2/s22002200L/m^2/sMAXIMUM
25TOB17PDSNUS-7725
Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION


%/min

%/minTARGET
26TOB17PDSNUS-7726
Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION


%/min

%/minMINIMUM
27TOB17PDSNUS-7727
Nicotine dissolution rateDESIGN PARAMETER SPECIFICATION


%/min

%/minMAXIMUM
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

The Tobacco Product Testing (PT) (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 (??? PD dataset).

**For  Pouch material porosity - which one should be the standard result?

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.

pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTREFIDPTTESTCDPTTESTPTTSTCNDPTCATPTSCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTREPNUMPTTPTPTTPTNUM
1TOB17PTSNUS-771

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

70

mm or cuts per inch

70

70

mm or cuts per inch1Week 01
2TOB17PTSNUS-772

Tobacco Moisture
DESIGN PARAMETER SPECIFICATION TEST RESULT
31.8%31.831.8%1Week 01
3TOB17PTSNUS-773

Portion Mass
DESIGN PARAMETER SPECIFICATION TEST RESULT
998mg998998mg1Week 01
4TOB17PTSNUS-774

Pouch material basis weight
DESIGN PARAMETER SPECIFICATION TEST RESULT
15.3g/m^215.315.3g/m^21Week 01
5TOB17PTSNUS-775

Pouch material porosity (permeability)
DESIGN PARAMETER SPECIFICATION TEST RESULT
1900L/m^2/s19001900L/m^2/s1Week 01
6TOB17PTSNUS-776

Nicotine dissolution rate
DESIGN PARAMETER SPECIFICATION TEST RESULT

%/min

%/min1Week 01
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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