---
kind: "section"
citation: "21 C.F.R. § 1114.1"
title: "21"
number: "1114.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/1114.1"
---

# §1114.1. Scope.

- (a) This part sets forth the procedures and requirements for submitting a premarket tobacco product application (PMTA), the general procedures FDA will follow when evaluating a PMTA, and postmarket reporting requirements.
- (b) This part does not apply to modified risk tobacco product applications, except that single applications seeking both a marketing granted order under [section 910(c)](/cfr/21/910.md?p=c) of the Federal Food, Drug, and Cosmetic Act and an order under [section 911(g)](/cfr/21/911.md?p=g) of the Federal Food, Drug, and Cosmetic Act must satisfy the requirements of this part in addition to the requirements of [section 911](/cfr/21/911.md) of the Federal Food, Drug, and Cosmetic Act.
- (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
- (d) This part does not apply to “premium” cigars as defined in [§ 1114.3](/cfr/21/1114.3.md).

## Notes

### Authority

Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49.

### Source

Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.