§1107.46. Issuance of an order finding a new tobacco product substantially equivalent. — Inbound Citations

(e) Issue an order as described in § 1107.46 finding the new tobacco product to be substantially equivalent and in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act; or

Each applicant that receives an order under § 1107.46 authorizing the marketing of a new tobacco product must maintain all records required by this subpart and that support the SE Report for a substantial equivalence order. These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. All records must be retained for a period of not less than 4 years from the date of the order even if such product is discontinued.

(c) After FDA issues an order under § 1107.46 finding a new tobacco product substantially equivalent, it will make the following information related to the SE Report and order available for public disclosure upon request or at FDA's own initiative, including information from amendments to the SE Report and FDA's reviews of the SE Report:

(1) All data previously disclosed to the public, as such disclosure is defined in § 20.81 of this chapter;

(2) Any protocol for a test or study, except to the extent it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61 of this chapter;

(3) Information and data submitted to demonstrate that the new tobacco product does not raise different questions of public health, except to the extent it is shown to fall within the exemptions established in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy;

(4) Correspondence between FDA and the applicant, including any requests FDA made for additional information and responses to such requests, and all written summaries of oral discussions between FDA and the applicant, except to the extent it is shown to fall within the exemptions in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy; and

(5) In accordance with § 25.51 of this chapter, the environmental assessment or, if applicable, the claim of categorical exclusion from the requirement to submit an environmental assessment under part 25 of this chapter.