; and (ii) be limited to such information that is needed to support the change. (B) Content Unless otherwise specified by the Secretary, a supplemental application under this subsection shall include— (i) a description of the change, including a rationale for implementing such change; (ii) a description of how the change was evaluated; (iii) data from a representative in vitro clinical test or tests that supports a showing that, in using the modified procedure or procedures, all eligible in vitro clinical tests within the scope of the technology certification will meet the applicable standard; (iv) as applicable, information to demonstrate that the modified procedure or procedures submitted under subsection (c)(2)(F) continue to conform to applicable requirements under section 587K; and (v) any other information requested by the Secretary. (3) Changes in response to a public health risk (A) In general If the holder of a technology certification makes a change to an in vitro clinical test or tests to address a potential risk to public health by adding a new specification or test method, such holder may immediately implement such change and shall submit a notification for such change to the Secretary within 30 days. (B) Content Any notification to the Secretary under this paragraph shall include— (i) a summary of the relevant change; (ii) the rationale for implementing such change; (iii) (I) if such a change necessitates a change to the procedures reviewed as part of the granted technology certification order, the modified procedures; or (II) if the procedures were not changed, an explanation as to why they were not changed