---
kind: "section"
citation: "21 C.F.R. § 1107.20"
title: "21"
number: "1107.20"
heading: "Amendments."
url: "https://uscodex.org/cfr/21/1107.20"
---

# §1107.20. Amendments.

- (a) Except as provided in paragraphs [(b)](#b) and [(c)](#c) of this section, the applicant may submit an amendment to an SE Report in accordance with [subpart C](/cfr/21/subpartC.md) of this part. If an applicant chose to submit a health information summary with its SE Report under [§ 1107.18(j)(1)](/cfr/21/1107.18.md?p=j-1), the applicant must submit with the amendment a redacted copy of the amendment that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ [20.61](/cfr/21/20.61.md) and [20.63](/cfr/21/20.63.md) of this chapter.
- (b) An applicant may not amend an SE Report to change the predicate tobacco product.
- (c) An applicant may not amend an SE Report after FDA has closed the SE Report under [§ 1107.44](/cfr/21/1107.44.md) or it has been withdrawn under [§ 1107.22](/cfr/21/1107.22.md).
- (d) In general, amendments will be reviewed in the next review cycle as described in [§ 1107.42](/cfr/21/1107.42.md).

## 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.