Health and Human Services Department Docket FDA-2016-N-3818 Proposed Rule

2019-05787: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports

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Summary

The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.

The agency’s own summary, as published.

What this changes

Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.

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