; or (ii) relates to national security or countermeasures is restricted from disclosure pursuant to statutory provisions other than this section. (3) Review of denials An applicant whose application submitted under subsection (c) or (d) has been denied approval may, by petition filed not more than 60 calendar days after the date on which the applicant receives notice of such denial, obtain review of the denial in accordance with section 587O. (h) Supplements to an application (1) Risk Analysis Prior to implementing any modification to an in vitro clinical test, the holder of the application approved under subsection (c) or (d) for such test shall perform risk analyses in accordance with section 587J, unless such modification is included in the change protocol submitted by the applicant and approved under this section or exempt under section 587A(l). (2) Supplement requirement (A) In general Except as provided in subparagraph (B), or otherwise specified by the Secretary, the holder of the application approved under subsection (g) for an in vitro clinical test shall submit to the Secretary and receive approval of a supplement before implementing a modification to the test, unless such modification is exempt under section 587A(l). (B) Adjustments to change protocol A person may submit under this paragraph a supplemental application adjusting the change protocol of the test at any time after the initial filing of an application under subsection (c) or (d). (C) Exceptions Subject to subparagraphs (D) and (E), and so long as the holder of an approved application submitted under subsection (c) or (d) for an in vitro clinical test does not add a manufacturing site, or change activities at an existing manufacturing site, with respect to the test, the holder may, without prior approval of a supplement, implement the following modifications to the test: (i) Modifications included in and implemented in accordance with an approved change protocol under subsection (c)(2)(I). (ii) Modifications that do not change— (I) the