THIS EXAMPLE IS UNDER RECONSTRUCTION FOLLOWING DISCUSSIONS ON THE TEAM CALL 17 JAN. Updates include: 1) Simplifying PD.xpt to one record per parameter and (2), simplifying TO.xpt to a parameter-based dataset
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
Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOPARMCD
TOPARM
TOCAT
TOVAL
TOVALU
1
TOB17
TO
SNUS-77
1
TBPRDCAT
Tobacco Product Category
PRODUCT IDENTIFIER
Smokeless Tobacco Product
2
TOB17
TO
SNUS-77
2
TBPRSCAT
Tobacco Product Subcategory
PRODUCT IDENTIFIER
Snus, portioned
3
TOB17
TO
SNUS-77
3
MANUF
Manufacturer
PRODUCT IDENTIFIER
Joes Smokeless
4
TOB17
TO
SNUS-77
4
TRADENAM
Trade Name
PRODUCT IDENTIFIER
Happy Dog Snus
5
TOB17
TO
SNUS-77
5
PACKTYP
Package Type
PRODUCT DESCRIPTOR
Plastic can and plastic lid
6
TOB17
TO
SNUS-77
6
Package Quantity
PRODUCT DESCRIPTOR
24
g
7
TOB17
TO
SNUS-77
7
Portion Mass
PRODUCT DESCRIPTOR
1
g
8
TOB17
TO
SNUS-77
8
Portion count
PRODUCT DESCRIPTOR
24
eaches or blank? - EACH?
9
TOB17
TO
SNUS-77
9
Portion length
PRODUCT DESCRIPTOR
30
mm
10
TOB17
TO
SNUS-77
10
Portion width
PRODUCT DESCRIPTOR
10
mm
11
TOB17
TO
SNUS-77
11
Portion thickness
5
mm
12
TOB17
TO
SNUS-77
12
Characterizing Flavor
Mint
13
TOB17
TO
SNUS-77
13
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
Row
STUDYID
DOMAIN
SPTOBID
PDSEQ
PDPARMCD
PDPARM
PDVALTRG
PDVALMIN
PDVALMAX
PDVALU
1
TOB17
PD
SNUS-77
1
Tobacco Cut Size or Tobacco Particle Size
70
65
75
mm or cuts per inch
2
TOB17
PD
SNUS-77
4
Tobacco Moisture
32.2
31
34
%
3
TOB17
PD
SNUS-77
7
Portion Length
38
36.5
39.5
mm
4
TOB17
PD
SNUS-77
10
Portion Width
16
15
17
mm
5
TOB17
PD
SNUS-77
13
Portion Mass
1000
900
1100
mg
6
TOB17
PD
SNUS-77
16
Portion (pouch) material thickness (if applicable)
0.06
0.055
0.065
mm
7
TOB17
PD
SNUS-77
19
Pouch material basis weight (if applicable)
16
15
17
g/m^2
8
TOB17
PD
SNUS-77
22
Pouch material porosity (permeability) (if applicable)
1850
1600
2200
L/m^2/s
9
TOB17
PD
SNUS-77
25
Nicotine dissolution rate
%/min
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.
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.