§ 1114.11 Withdrawal by applicant.
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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
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(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(b) An application will be considered withdrawn when FDA issues an acknowledgement letter stating that the application has been withdrawn.
(c) The application is an Agency record, even if withdrawn. FDA will retain the withdrawn application under Federal Agency records schedules. The availability of the withdrawn application will be subject to FDA's public information regulation in Part 20 of this chapter.
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