complaints that are solely regarding efficacy and do not contain any information about an adverse event. The Food and Drug Administration shall further specify the contents of the annual electronic report by regulation or guidance. (C) Small business exception In the case of a domestic facility for which the average gross annual sales in cosmetic products in the United States over the previous 3-year period is not more than $2,000,000, the responsible person is not required to submit an annual report under this paragraph. (4) Exemption The Food and Drug Administration may establish by regulation an exemption to any of the requirements under this subsection if the Food and Drug Administration determines that such exemption is supported by adequate evidence and would have no adverse effect on public health. (d) Requirements (1) In general Each serious adverse event report under this section shall be submitted to the Food and Drug Administration using an electronic system of the Food and Drug Administration. The Food and Drug Administration shall make such electronic system available not later than 1 year after the date of enactment of the Personal Care Products Safety Act . (2) Modification The format of the reporting system may be modified by the Food and Drug Administration and the reports may include additional information. The Food and Drug Administration may, in guidance, further specify the format and contents of required reports. (3) Scope of serious adverse event report A serious adverse event report (including all information submitted in the initial report or added later) submitted to the Food and Drug Administration under subsection (a) includes— (A) a report under section 756 with respect to safety and related to a specific cosmetic product