§ 1107.22. Withdrawal by applicant.

132 words·~1 min read·/us/cfr/t21/s§ 1107.22·

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(a)An applicant may at any time make a written request to withdraw an SE Report for which FDA has not issued an order. The withdrawal request must state:

(1)Whether the withdrawal is due to a health or safety concern related to the tobacco product;

(2)The submission tracking number; and

(3)The name of the new tobacco product that is the subject of the SE Report.

(b)An SE Report will be considered withdrawn when FDA issues a notice stating the SE Report has been withdrawn.

(c)The SE Report is an Agency record, even if withdrawn. FDA will retain the withdrawn SE Report under Federal Agency records schedules. The availability of the withdrawn SE Report will be subject to FDA's public information regulations in part 20 of this chapter.

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§ 1107.22

Withdrawal by applicant.

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