Part 1114 — Premarket Tobacco Product Applications
Current through Sep 8, 2026
Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49.
Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.
Sections
- § 1114.1 Scope.
- § 1114.3 Definitions.
- § 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.
- § 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.
- § 1114.39 Postmarket changes.
- § 1114.41 Reporting requirements.
- § 1114.45 Record retention.
- § 1114.47 Confidentiality.
- § 1114.49 Electronic submission.