# Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
> **Food and Drug Administration** · Final rule. · Published 2021-10-05 · Effective 2021-11-04 · 86 FR 55224
## Document
- **Document number:** 2021-21009
- **Category:** fda-tobacco
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 86 FR 55224
- **CFR reference:** 21 CFR 16
- **Publication date:** 2021-10-05
- **Effective date:** 2021-11-04
- **HHS docket:** Docket No. FDA-2016-N-3818
## Abstract

The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2021/10/05/2021-21009/content-and-format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on)
---
*AI Analytics · CC0 1.0*