; (iii) acceptance criteria; and (iv) any revised labeling; and (B) for manufacturing site changes— (i) the information listed in subparagraph (A); and (ii) information regarding the methods used in, or the facilities or controls used for, the development of the test to demonstrate compliance with the applicable quality requirements under section 587K. (4) Additional data The Secretary may require, when necessary, data to evaluate a modification to an in vitro clinical test that is in addition to the data otherwise required under the preceding paragraphs if the data request is in accordance with the least burdensome requirements under section 587AA(c). (5) Conditions of approval In an order approving a supplement under this subsection, the Secretary may require conditions of approval for the in vitro clinical test, including compliance with restrictions under section 587O and conformance to performance standards under section 587R. (6) Approval The Secretary shall approve a supplement under this subsection if— (A) the data demonstrate that the modified in vitro clinical test meets the applicable standard; and (B) the holder of the application approved under subsection (e) for the test has demonstrated compliance with applicable quality and inspection requirements, as applicable and appropriate. (7) Publication The Secretary shall publish on the public website of the Food and Drug Administration notice of any order approving a supplement under this subsection provided that doing so does not disclose any information that— (A) is trade secret or confidential commercial or financial information