(a) General. FDA will determine the public availability of any part of an SE Report and other content related to such an SE Report under this section and part 20 of this chapter.
(b) Confidentiality of data and information prior to an order. Prior to issuing an order under this section:
(1) FDA will not publicly disclose the existence of an SE Report unless:
(i) The tobacco product has been introduced or delivered for introduction into interstate commerce for commercial distribution; or
(ii) The applicant has publicly disclosed or acknowledged the existence of the SE Report (as such disclosure is defined in § 20.81 of this chapter), or has authorized FDA in writing to publicly disclose or acknowledge, that the applicant has submitted the SE Report to FDA.
(2) FDA will not disclose the existence of or contents of an FDA communication with an applicant regarding its SE Report except to the extent that the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence of or contents of that particular FDA communication.
(3) FDA will not disclose information contained in an SE Report unless the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, that particular information. If the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, that particular information contained in an SE Report, FDA may disclose that particular information.
(c) Disclosure of data and information after issuance of an order under § 1107.46. 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.
(d) Disclosure of data and information after issuance of an order under § 1107.48. After FDA issues an order under § 1107.48 (denying marketing authorization), FDA may make certain information related to the SE Report and the order available for public disclosure upon request or at FDA's own initiative except to the extent the information is otherwise exempt from disclosure under part 20 of this chapter. Information FDA may disclose includes the tobacco product category (e.g., cigarette), tobacco product subcategory (e.g., filtered), package size, and the basis for the order denying marketing authorization.
(e) Health information summary or statement. Health information required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act, if submitted as part of the SE Report (which includes any amendments), will be disclosed within 30 calendar days of issuing a substantially equivalent order. If the applicant has instead submitted a 910(a)(4) statement as provided in § 1107.18(j)(2), FDA will make publicly available on FDA's website the responsible official to whom a request for health information may be made.
