21 CFR § 1114.29 - FDA action on an application.

---
identifier: "/us/cfr/t21/s1114.29"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1114.29 - FDA action on an application."
title_number: 21
title_name: "Food and Drugs"
section_number: "1114.29"
section_name: "FDA action on an application."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "K"
subchapter_name: "TOBACCO PRODUCTS"
part_number: "1114"
part_name: "PREMARKET TOBACCO PRODUCT APPLICATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49."
regulatory_source: "86 FR 55412, Oct. 4, 2021, unless otherwise noted."
cfr_part: "1114"
---


# 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);

(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);

(e) Issue a marketing granted order as described in § 1114.31; or

(f) Issue a marketing denial order as described in § 1114.33.