---
kind: "section"
citation: "21 C.F.R. § 1114.11"
title: "21"
number: "1114.11"
heading: "Withdrawal by applicant."
url: "https://uscodex.org/cfr/21/1114.11"
---

# §1114.11. Withdrawal by applicant.

- (a) An applicant may at any time make a written request using the appropriate form to withdraw a PMTA that FDA has not acted on as described in [§ 1114.29](/cfr/21/1114.29.md). The withdrawal request must state:
  - (1) Whether the withdrawal is due to a health concern related to the tobacco product and, if so, a description of those concerns, including the extent, duration, and frequency of the health effects, and what gave rise to the concerns, such as reports of adverse experiences;
  - (2) The application STN; and
  - (3) **The name(s) of the new tobacco product that is the subject of the application.**
- (b) An application will be considered withdrawn when FDA issues an acknowledgement letter stating that the application has been withdrawn.
- (c) **The application is an Agency record, even if withdrawn.** FDA will retain the withdrawn application under Federal Agency records schedules. The availability of the withdrawn application will be subject to FDA's public information regulation in [Part 20](/cfr/21/part20.md) of this chapter.

## 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.