; the failure to perform a risk analysis required by section 587B; the failure to submit an annual update required under section 587J(c)(2)(B); or the failure to complete postmarket surveillance as required under section 587X. (6) The failure to comply with applicable requirements to submit an application or report under section 587D(e). (7) The failure to comply with applicable mitigating measures established under section 587E or to submit, maintain, or make available the documentation required under section 587E(b); or the failure to comply with applicable performance standards established under section 587R. (8) The failure to register in accordance with section 587J, the failure to provide information required under section 587J(b), or the failure to maintain or submit information required under section 587J(c). (9) The failure to comply with requirements under section 587M or 587N, the failure to comply with a restriction required under section 587O, or the failure to comply with labeling and advertising requirements under section 587O(b). (10) The failure to comply with the requirements of section 587Q. (11) The failure to comply with any requirement of section 587S; the failure to furnish any notification, information, material, or report required under section 587S; or the failure to comply with an order issued under section 587S. (12) The failure to furnish information requested by the Secretary under 587G(d)(2). . (b) Penalties Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended— (1) in subsection (b)(8), by inserting or counterfeit in vitro clinical test after counterfeit drug ; (2) in subsection (c)— (A) by striking ; or (5) and inserting ; (5) ; and (B) by inserting before the period at the end the following: