; and (ii) any other information that the Secretary determines to relate to national security or countermeasures or to be restricted from disclosure pursuant to another provision of law. (2) Order of temporary suspension If, after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section, the Secretary determines there is a reasonable likelihood that the in vitro clinical test would cause death or serious adverse health consequences, including by causing the absence, delay, or discontinuation of life-saving or life-sustaining medical treatment, the Secretary shall by order temporarily suspend the approval of the application. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw approval of such application. (j) Least burdensome requirements (1) In general In carrying out this subchapter, the Secretary shall consider the least burdensome means necessary to provide a reasonable assurance of analytical and clinical validity, or applicable standard, and other regulatory requirements, as determined by the Secretary. (2) Necessary defined For purposes of paragraph (1) and paragraph (3), the term necessary means the minimum required information that would support a determination by the Secretary that the application provides a reasonable assurance of analytical and clinical validity, or other applicable standard or regulatory requirement, as determined by the Secretary. (3) Consideration of role of postmarket information For purposes of this subsection, the Secretary shall consider the role of postmarket information in determining the least burdensome appropriate means necessary to demonstrate that the applicable standard 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