---
kind: "section"
citation: "21 C.F.R. § 1114.29"
title: "21"
number: "1114.29"
heading: "FDA action on an application."
url: "https://uscodex.org/cfr/21/1114.29"
---

# §1114.29. FDA action on an application.


After receipt of an application, FDA will:

- (a) Refuse to accept the application as described in [§ 1114.27(a)](/cfr/21/1114.27.md?p=a);
- (b) Issue a letter administratively closing the application;
- (c) Issue a letter canceling the application if FDA finds that it mistakenly accepted the application or that the application was submitted in error;
- (d) Refuse to file the application as described in [§ 1114.27(b)](/cfr/21/1114.27.md?p=b);
- (e) Issue a marketing granted order as described in [§ 1114.31](/cfr/21/1114.31.md); or
- (f) Issue a marketing denial order as described in [§ 1114.33](/cfr/21/1114.33.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.