§ 1107.24. Change in ownership of an SE Report.

245 words·~1 min read·/us/cfr/t21/s§ 1107.24·

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An applicant may transfer ownership of its SE Report. On or before the time of transfer, the new and former applicants are required to submit information to FDA as follows:

(a)The former applicant must sign and submit a notice to FDA that states that all of the former applicant's rights and responsibilities relating to the SE Report have been transferred to the new applicant. This notice must identify the name and address of the new applicant and the SE Report transferred.

(b)The new applicant must sign and submit a notice to FDA containing the following:

(1)The new applicant's commitment to agreements, promises, and conditions made by the former applicant and contained in the SE Report;

(2)The date that the change in ownership is effective;

(3)Either a statement that the new applicant has a complete copy of the SE Report and order (if applicable), including amendments and records that are required to be kept under § 1107.58, or a request for a copy of the SE Report from FDA's files by submitting a request in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the SE Report to the new applicant under the fee schedule in FDA's public information regulations in § 20.45 of this chapter; and

(4)A certification that no modifications have been made to the new tobacco product since the SE Report was submitted to FDA.

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§ 1107.24

Change in ownership of an SE Report.

Fed. Reg.×2

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