CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR1114.11]

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 B - Premarket Tobacco Product Applications

Sec. 1114.11 Withdrawal by applicant.

(a) An applicant may at any time make a written request using the appropriate form to withdraw a PMTA that FDA has not acted on as described in § 1114.29. The withdrawal request must state:

(1) Whether the withdrawal is due to a health concern related to the tobacco product and, if so, a description of those concerns, including the extent, duration, and frequency of the health effects, and what gave rise to the concerns, such as reports of adverse experiences;

(2) The application STN; and

(3) The name(s) of the new tobacco product that is the subject of the application.

(b) An application will be considered withdrawn when FDA issues an acknowledgement letter stating that the application has been withdrawn.

(c) The application is an Agency record, even if withdrawn. FDA will retain the withdrawn application under Federal Agency records schedules. The availability of the withdrawn application will be subject to FDA's public information regulation in Part 20 of this chapter.