This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST)
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
PACKQUAN
Package Quantity
PRODUCT DESCRIPTOR
24
g
7
TOB17
TO
SNUS-77
7
PORTMASS
Portion Mass
PRODUCT DESCRIPTOR
1
g
8
TOB17
TO
SNUS-77
8
PORTCONT
Portion count
PRODUCT DESCRIPTOR
24
eaches or blank? - EACH?
9
TOB17
TO
SNUS-77
9
PRTLENG
Portion length
PRODUCT DESCRIPTOR
30
mm
10
TOB17
TO
SNUS-77
10
PRTWDTH
Portion width
PRODUCT DESCRIPTOR
10
mm
11
TOB17
TO
SNUS-77
11
PRTTHICK
Portion thickness
PRODUCT DESCRIPTOR
5
mm
12
TOB17
TO
SNUS-77
12
CHARFLAV
Characterizing Flavor
PRODUCT DESCRIPTOR
Mint
13
TOB17
TO
SNUS-77
13
ADDPROP
Additional property
PRODUCT DESCRIPTOR
n/a
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Product Design Parameters (PD) domain is used to represent design specification parameters of the tobacco product. Each property is identified using controlled terminology and is stored in PDPARMCD/PDPARM.
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
TOCUTSIZ
Tobacco Cut Size
70
65
75
cuts per inch
2
TOB17
PD
SNUS-77
1
TOPRTSIZ
Tobacco Particle Size
70
65
75
mm
3
TOB17
PD
SNUS-77
2
TOMOISTR
Tobacco Moisture
32.2
31
34
%
4
TOB17
PD
SNUS-77
3
PRTLENG
Portion Length
38
36.5
39.5
mm
5
TOB17
PD
SNUS-77
4
PRTWDTH
Portion Width
16
15
17
mm
6
TOB17
PD
SNUS-77
5
PRTMASS
Portion Mass
1000
900
1100
mg
7
TOB17
PD
SNUS-77
6
PRTTHICK
Portion (pouch) material thickness (if applicable)
0.06
0.055
0.065
mm
8
TOB17
PD
SNUS-77
7
PRTMWGT
Pouch material basis weight (if applicable)
16
15
17
g/m^2
9
TOB17
PD
SNUS-77
8
PRTMPOR
Pouch material porosity (permeability) (if applicable)
1850
1600
2200
L/m^2/s
10
TOB17
PD
SNUS-77
9
NICTDSRT
Nicotine dissolution rate
15
5
22
%/min
$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.