and other regulatory requirements have been met. (k) Annual report (1) In general Unless the Secretary specifies otherwise, the holder of an approved application under this section shall submit an annual report each year at a time designated by the Secretary in the approval order. Such report shall— (A) identify all modifications required to be reported that an approved application holder has made to any test that is covered by the approval order, including any modification that requires a supplement under subsection (h)(2)