GroundRules
21 CFR 1114.29: FDA action on an application.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER K—TOBACCO PRODUCTS
- PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS
- Subpart C—FDA Review
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON