---
kind: "section"
citation: "21 C.F.R. § 1107.22"
title: "21"
number: "1107.22"
heading: "Withdrawal by applicant."
url: "https://uscodex.org/cfr/21/1107.22"
---

# §1107.22. Withdrawal by applicant.

- (a) An applicant may at any time make a written request to withdraw an SE Report for which FDA has not issued an order. The withdrawal request must state:
  - (1) Whether the withdrawal is due to a health or safety concern related to the tobacco product;
  - (2) The submission tracking number; and
  - (3) **The name of the new tobacco product that is the subject of the SE Report.**
- (b) An SE Report will be considered withdrawn when FDA issues a notice stating the SE Report has been withdrawn.
- (c) **The SE Report is an Agency record, even if withdrawn.** FDA will retain the withdrawn SE Report under Federal Agency records schedules. The availability of the withdrawn SE Report will be subject to FDA's public information regulations in [part 20](/cfr/21/part20.md) of this chapter.

## Notes

### Source

Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted.

### Authority

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

### Source

Source: 76 FR 38974, July 5, 2011, unless otherwise noted.