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  1. Economic Impact Analyses of FDA Regulations

Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Final Rule; Final Regulatory Impact Analysis

This final rule codifies the specific format and content of substantial equivalence reports for tobacco products. If the new tobacco product has some characteristics that are identical to a valid predicate, but some characteristics are not identical, the applicant may submit an SE Report and choose to certify that certain characteristics are identical (e.g., product quantity changes). The final rule will clarify when manufacturers can certify that certain characteristics are identical.

Regulatory Impact Analysis

Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Final Rule; Final Regulatory Impact Analysis (PDF- 618KB)

Docket: FDA-2016-N-3818

Federal Register: 86 FR 55224, October 10, 2021

 

 

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