§1107.19. Comparison information. — Inbound Citations

(2) The SE Report must include the following certification, as well as a justification for the certification, if an applicant chooses to certify that certain characteristics are identical in lieu of providing data for each characteristic of the new and predicate tobacco products. This certification must include the appropriate information inserted (as indicated by parenthetical text) and be signed by an authorized representative of the applicant: “I, (name of responsible official), on behalf of (name of company), certify that (new tobacco product name) has the following modification(s) as compared to (name of predicate tobacco product): (describe modification(s), e.g., change in product quantity or change in container closure system). Aside from these modifications, the characteristics of (new tobacco product name) and (name of predicate tobacco product) are identical. I certify that (name of company) understands this means there is no other modification to the materials, ingredients, design features, heating source, or any other feature. I also certify that (name of company) will maintain records to support the comparison information in 21 CFR 1107.19 that substantiate the accuracy of this statement for the period of time required in 21 CFR 1107.58, and ensure that such records remain readily available to FDA upon request.”

(d) FDA will make reasonable efforts to communicate to applicants the procedural, administrative, or scientific deficiencies found in an SE Report and any additional information and data needed for the Agency's review. The applicant must also provide additional comparison information under § 1107.19 if requested by FDA.