CFR › Title 21 › Part 1107Part 1107 — Exemption Requests and Substantial Equivalence ReportsSubpart A — Exemptions§ 1107.1— Exemptions.§ 1107.3— Recordkeeping.Subpart B — General§ 1107.10— Scope.§ 1107.12— Definitions.Subpart C — Substantial Equivalence Reports§ 1107.16— Submission of a substantial equivalence report.§ 1107.18— Required content and format of an SE Report.§ 1107.19— Comparison information.§ 1107.20— Amendments.§ 1107.22— Withdrawal by applicant.§ 1107.24— Change in ownership of an SE Report.Subpart D — FDA Review§ 1107.40— Communications between FDA and applicants.§ 1107.42— Review cycles.§ 1107.44— FDA action on an SE Report.§ 1107.46— Issuance of an order finding a new tobacco product substantially equivalent.§ 1107.48— Issuance of an order denying marketing authorization.§ 1107.50— Rescission of order.Subpart E — Miscellaneous§ 1107.58— Record retention.§ 1107.60— Confidentiality.§ 1107.62— Electronic submission.