§ 1114.13. Change in ownership of an application.
267 words·~1 min read·
/us/cfr/t21/s§ 1114.13·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
An applicant may transfer ownership of a PMTA. At or before the time of transfer, the new owner and the former owner must submit information to FDA using the appropriate form as follows:
(a)The new and former owner must sign and submit a notice to FDA stating that all of the former applicant's rights and responsibilities relating to the PMTA have been transferred to the new owner. This notice must identify the name and address of the new owner and the PMTA transferred by tobacco product name(s) and STN.
(b)The new owner must sign and submit a notice to FDA containing the following:
(1)The new owner's commitment to agreements, promises, and conditions made by the former owner and contained in the application and marketing granted order, if applicable;
(2)The date that the change in ownership is effective;
(3)Either a statement that the new owner has a complete copy of the application, including all amendments, the marketing granted order (if applicable), and any records that are required to be kept under § 1114.45, or a request for a copy of the application, including all amendments, and the modified risk order (if applicable) from FDA's files in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the application to the new owner 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 tobacco product since the application, including amendments (if any), was submitted to FDA.