; (iv) a persistent or significant disability, incapacity, or disfigurement; (v) a congenital abnormality or birth defect; or (vi) permanent alteration of appearance other than as intended, under conditions of use that are customary or usual; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in subparagraph (A). (3) The term serious adverse event report means a report that is required to be submitted to the Secretary under subsection (b). (b) Reporting requirement The manufacturer or distributor of a cosmetic whose name appears on the label of such cosmetic pursuant to section 602 (referred to in this section as a responsible person ) shall submit to the Secretary any report received of a serious adverse event associated with such cosmetic when used in the United States, accompanied by a copy of the label on or within the retail packaging of such cosmetic. (c) Submission of reports (1) Timing of reports The responsible person shall submit to the Secretary a serious adverse event report no later than 15 business days after the report is received. (2) New medical information The responsible person shall submit to the Secretary any new and material medical information, related to a submitted serious adverse event report that is received by the responsible person within 1 year of the initial report, no later than 15 business days after such information is received by such responsible person. (3) Consolidation of reports The Secretary shall provide for systems to enable responsible persons to submit a single report that includes duplicate reports of, or new medical information related to, a serious adverse event. (4) Exemption The Secretary may establish an exemption to the requirements under paragraphs (1) and (2) if— (A) the Secretary receives a report in accordance with section 760