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Part 1107
FEDERAL · 21 CFR
Part 1107 — Exemption Requests and Substantial Equivalence Reports
19 sections · Title 21: Food and Drugs
§ 1107.1
Exemptions.
§ 1107.3
Recordkeeping.
§ 1107.10
Scope.
§ 1107.12
Definitions.
§ 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.
§ 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.
§ 1107.58
Record retention.
§ 1107.60
Confidentiality.
§ 1107.62
Electronic submission.