§1107.58. Record retention. — Inbound Citations

(g) The SE Report must include a comparison of the characteristics of the new tobacco product and the predicate tobacco product. If the new tobacco product has limited changes to a characteristic(s) when compared to the predicate tobacco product, and all other characteristics are identical (e.g., a change to product quantity), the applicant must provide comparison information related to any characteristic(s) that have changed, but may certify that the other characteristics are identical under paragraph (l)(2) of this section. The applicant must maintain records supporting the certification consistent with § 1107.58.

(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