; and (ii) include in the report— (I) a summary of the relevant change or changes; (II) the rationale for implementing such change or changes; and (III) a description of how the change or changes were evaluated. (F) Request for supplement Upon review of the information received under subparagraph (D) and a finding that the relevant modification is inconsistent with the standard specified under subparagraph (C), the Secretary may require a supplement under subparagraph (A). If the Secretary determines that a supplement under subparagraph (A) is required, the Secretary shall notify the applicant of such determination. Such notification shall include a justification for the submission of a supplement. Prior to the submission of a supplement under this subparagraph, the applicant may request a meeting or written correspondence to gain agency feedback as to the necessity of such supplemental filing. The Secretary shall respond to such meeting request within 30 calendar days of receipt. (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— (i) a description of the modification; (ii) data to demonstrate that the applicable standard is met; (iii) acceptance criteria; and (iv) any revised labeling; and (B) for manufacturing site changes— (i) the matter listed in subparagraph (A)