; or (B) requires, based on appropriate medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A). (c) Submission of reports (1) Serious adverse event reports Except as provided in paragraph (2), with respect to a cosmetic product distributed in the United States, the responsible person shall submit a serious adverse event report to the Food and Drug Administration not later than 15 business days after information concerning the adverse event is received. If a serious adverse event report for a cosmetic with drug properties is filed using Form FDA 3500A (or any successor form developed for such purpose) or its electronic equivalent for over-the-counter drugs, the responsible person shall not have to submit a duplicative serious adverse event report under this section. (2) New medical information The responsible person shall submit to the Food and Drug Administration any new medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, and shall submit such information not later than 15 business days after the new information is received by the responsible person. (3) Annual report (A) In general Not later than March 1 of each year, except as provided under subparagraph (C), the responsible person shall submit an electronic report for the prior calendar year for each cosmetic product marketed during that year. (B) Contents Each report under this paragraph shall contain a summary of all adverse events received during the reporting period, a complete list of individual reports, and an estimate of the total number of product units estimated to have been distributed to consumers during such period. The report shall not include consumer 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