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Observations about tobacco products and study subjects generated to support a submission are represented in a series of datasets aligned with logical groupings of data per domains. Domains described in this guide are generally aligned with implementation of a single dataset in which to represent data in scope for a domain.All datasets are structured as flat files with rows representing observations and columns representing variables.In some cases, a dataset implemented for a domain may be split into physically separate datasets to support submission when needed and as allowable by the regulatory authority. 

domain datasets and other datasets

The following guidance will be adhered to when implementing tabulation datasets: 

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