; or (B) after providing notice and an opportunity for comment from interested parties, the Secretary determines that such exemption would have no significant adverse effect on public health. (d) Content of report Each serious adverse event report under this section shall be submitted to the Secretary, and may be accompanied by additional information. (e) Maintenance and inspection of records (1) Maintenance The responsible person shall maintain records related to each report of a serious adverse event received by the responsible person for a period of 6 years. (2) Records inspection (A) In general The responsible person shall permit an authorized person to have access to records required to be maintained under this section during an inspection pursuant to section 704. (B) Authorized person For purposes of this paragraph, the term authorized person means an officer or employee of the Department of Health and Human Services, who has— (i) appropriate credentials, as determined by the Secretary; and (ii) been duly designated by the Secretary to have access to the records required under this section. (f) Protected information A serious adverse event report submitted to the Secretary under this section, including any new medical information submitted under subsection (c)(2), or an adverse event report voluntarily submitted to the Secretary shall be considered to be— (1) a safety report under section 756 and may be accompanied by a statement, which shall be a part of any report that is released for public disclosure, that denies that the report or the records constitute an admission that the product involved caused or contributed to the adverse event