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Form FDA 4057b PMTA Unique Identifying Information for New Tobacco Products (formerly referred to as a grouping spreadsheet) Contain a comprehensive index (i.e., a listing of files and data associated with those files) Contain a table of contents Be well-organized and legible Be written in English (see 21 CFR 1114.7(b) for requirements related to documents that have been translated from another language into English) Be submitted in an electronic format that FDA can process, read, review, and archive, unless FDA has granted a waiver How Do I Prepare Supplemental PMTAs and Resubmissions

Clinical Pharmacogenetics Implementation Consortium guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A genotypes and serotonin reuptake inhibitor antidepressants

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