21 CFR Part 1107
PART 1107—EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
- PART 1107—EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter K—Tobacco Products
- Subpart 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.
Feedback