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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter K - Tobacco Products |
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Part 1107 - Exemption Requests and Substantial Equivalence Reports |
| 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. |