; and (ii) include in such report— (I) a description of the modification; (II) the rationale for implementing such modification; and (III) as applicable, a summary of the evidence supporting that the test, as modified, meets the applicable standard, complies with performance standards required under section 587Q, and complies with any mitigating measures established under section 587E and any restrictions under section 587O. (E) Reporting for certain safety related labeling changes The holder of the application for an in vitro clinical test approved under subsection (e) shall— (i) report to the Secretary any modification to the test described in subparagraph (C)(iii) not more than 30 days after the date on which the test, with the modification, is introduced into interstate commerce; and (ii) include in the report— (I) a description of the change or changes; (II) the rationale for implementing such change or changes; and (III) a description of how the change or changes were evaluated. (3) Contents of supplement Unless otherwise specified by the Secretary, a supplement under this subsection shall include— (A) for modifications other than manufacturing site changes requiring a supplement— (i) a description of the modification; (ii) data relevant to the modification to demonstrate that the applicable standard is met, not to exceed data requirements for the original submission; (iii) acceptance criteria; and (iv) any revised labeling; and (B) for manufacturing site changes— (i) the information listed in subparagraph (A)