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