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title	Tobacco domains

DI = TO for Tobacco Product IdentifierIdentifiers and Descriptors

SPDEVID = SPTOBID for Sponsor Tobacco Product Identifier

DO/DU = ~~Tobacco~~ Product Design Parameters (DPPD)

LB = Tobacco Product Testing (TT)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.

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Dataset wrap

Name	to

Rowcaps

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.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOORRESU	TOSTRESC
1	TOB17	TO	SNUS-77	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	Smokeless Tobacco Product		Smokeless Tobacco Product
2	TOB17	TO	SNUS-77	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Snus, portioned		Snus, portioned
3	TOB17	TO	SNUS-77	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Smokeless		Joes Smokeless
4	TOB17	TO	SNUS-77	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Happy Dog Snus		Happy Dog Snus
5	TOB17	TO	SNUS-77	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	Plastic can and plastic lid		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

The ~~Tobacco~~ Design Parameters (DPPD) 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.

Dataset wrap

Name	dppd

Rowcaps

Rows 1-27:	Show the design parameter specification with target, minimum, and maximum value reflected in the DPCOLSRT PDCOLSRT variable.
Rows 7-18:	Show the design parameter specification for portioned characteristics.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	DPSEQPDSEQ	DPTESTPDTEST	DPTSTCNDPDTSTCND	DPSCATPDSCAT	DPCOLSRTPDCOLSRT
1	TOB17	DPPD	SNUS-77	1	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION	mm or cuts per inch	TARGET
2	TOB17	DPPD	SNUS-77	2	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION	mm or cuts per inch	MINIMUM
3	TOB17	DPPD	SNUS-77	3	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION	mm or cuts per inch	MAXIMUM
4	TOB17	DPPD	SNUS-77	4	Tobacco Moisture	DESIGN PARAMETER SPECIFICATION	%	TARGET
5	TOB17	DPPD	SNUS-77	5	Tobacco Moisture	DESIGN PARAMETER SPECIFICATION	%	MINIMUM
6	TOB17	DPPD	SNUS-77	6	Tobacco Moisture	DESIGN PARAMETER SPECIFICATION	%	MAXIMUM
7	TOB17	DPPD	SNUS-77	7	Portion Length	DESIGN PARAMETER SPECIFICATION	mm	TARGET
8	TOB17	DPPD	SNUS-77	8	Portion Length	DESIGN PARAMETER SPECIFICATION	mm	MINIMUM
9	TOB17	DPPD	SNUS-77	9	Portion Length	DESIGN PARAMETER SPECIFICATION	mm	MAXIMUM
10	TOB17	DPPD	SNUS-77	10	Portion Width	DESIGN PARAMETER SPECIFICATION	mm	TARGET
11	TOB17	DPPD	SNUS-77	11	Portion Width	DESIGN PARAMETER SPECIFICATION	mm	MINIMUM
12	TOB17	DPPD	SNUS-77	12	Portion Width	DESIGN PARAMETER SPECIFICATION	mm	MAXIMUM
13	TOB17	DPPD	SNUS-77	13	Portion Mass	DESIGN PARAMETER SPECIFICATION	mg	TARGET
14	TOB17	DPPD	SNUS-77	14	Portion Mass	DESIGN PARAMETER SPECIFICATION	mg	MINIMUM
15	TOB17	DPPD	SNUS-77	15	Portion Mass	DESIGN PARAMETER SPECIFICATION	mg	MAXIMUM
16	TOB17	DPPD	SNUS-77	16	Portion (pouch) material thickness (if applicable)	DESIGN PARAMETER SPECIFICATION	mm	TARGET
17	TOB17	DPPD	SNUS-77	17	Portion (pouch) material thickness (if applicable)	DESIGN PARAMETER SPECIFICATION	mm	MINIMUM
18	TOB17	DPPD	SNUS-77	18	Portion (pouch) material thickness (if applicable)	DESIGN PARAMETER SPECIFICATION	mm	MAXIMUM
19	TOB17	DPPD	SNUS-77	19	Pouch material basis weight (if applicable)	DESIGN PARAMETER SPECIFICATION	g/m^2	TARGET
20	TOB17	DPPD	SNUS-77	20	Pouch material basis weight (if applicable)	DESIGN PARAMETER SPECIFICATION	g/m^2	MINIMUM
21	TOB17	DPPD	SNUS-77	21	Pouch material basis weight (if applicable)	DESIGN PARAMETER SPECIFICATION	g/m^2	MAXIMUM
22	TOB17	DPPD	SNUS-77	22	Pouch material porosity (permeability) (if applicable)	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or L/m^2/s	TARGET
23	TOB17	DPPD	SNUS-77	23	Pouch material porosity (permeability) (if applicable)	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or L/m^2/s	MINIMUM
24	TOB17	DPPD	SNUS-77	24	Pouch material porosity (permeability) (if applicable)	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or L/m^2/s	MAXIMUM
25	TOB17	DPPD	SNUS-77	25	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION	%/min	TARGET
26	TOB17	DPPD	SNUS-77	26	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION	%/min	MINIMUM
27	TOB17	DPPD	SNUS-77	27	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION	%/min	MAXIMUM

The Tobacco Product Testing (TTPT) (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 PD dataset).

Dataset wrap

Name	ttpt

Rowcaps

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.

Dataset2

Row	STUDYID	DOMAIN	SPTOBID	TTSEQPTSEQ	TTTESTPTTEST	TTCATPTCAT	TTORRESUPTORRESU
1	TOB17	TTPT	SNUS-77	1	Tobacco Cut Size or Tobacco Particle Size	DESIGN PARAMETER SPECIFICATION TEST RESULT	mm or cuts per inch
2	TOB17	TTPT	SNUS-77	2	Tobacco Moisture	DESIGN PARAMETER SPECIFICATION TEST RESULT	%
3	TOB17	TTPT	SNUS-77	3	Portion Mass	DESIGN PARAMETER SPECIFICATION TEST RESULT	mg
4	TOB17	TTPT	SNUS-77	4	Pouch material basis weight	DESIGN PARAMETER SPECIFICATION TEST RESULT	g/m^2
5	TOB17	TTPT	SNUS-77	5	Pouch material porosity (permeability)	DESIGN PARAMETER SPECIFICATION TEST RESULT	CORESTA Unit (Cu) or L/m^2/s
6	TOB17	TTPT	SNUS-77	6	Nicotine dissolution rate	DESIGN PARAMETER SPECIFICATION TEST RESULT	%/min

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