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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 1114 - Premarket Tobacco Product Applications |
| Subpart A - General Provisions |
| § 1114.1 - Scope. |
| § 1114.3 - Definitions. |
| Subpart B - Premarket Tobacco Product Applications |
| § 1114.5 - Application submission. |
| § 1114.7 - Required content and format. |
| § 1114.9 - Amendments. |
| § 1114.11 - Withdrawal by applicant. |
| § 1114.13 - Change in ownership of an application. |
| § 1114.15 - Supplemental applications. |
| § 1114.17 - Resubmissions. |
| Subpart C - FDA Review |
| § 1114.25 - Communication between FDA and applicants. |
| § 1114.27 - Review procedure. |
| § 1114.29 - FDA action on an application. |
| § 1114.31 - Issuance of a marketing granted order. |
| § 1114.33 - Issuance of a marketing denial order. |
| § 1114.35 - Withdrawal of a marketing granted order. |
| § 1114.37 - Temporary suspension of a marketing granted order. |
| Subpart D - Postmarket Requirements |
| § 1114.39 - Postmarket changes. |
| § 1114.41 - Reporting requirements. |
| Subpart E - Miscellaneous |
| § 1114.45 - Record retention. |
| § 1114.47 - Confidentiality. |
| § 1114.49 - Electronic submission. |