; penalties The Secretary shall conduct an annual review of observational registries established under this subsection. If, at such an annual review, fewer than 90 percent of patients are participating in an observational registry with respect to a drug approved under this section, the Secretary shall issue to the sponsor of such drug a civil monetary penalty of not more than $100,000. If a violation of this section is not corrected within the 30-day period following notification, the sponsor shall, in addition to any penalty under this subparagraph be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected. If application patient participation in an observational registry is not at or above 90 percent within 6 months of issuance of such penalty, the provisional approval shall be withdrawn. (4) Annual report to Congress The Secretary shall submit an annual report to Congress on all drugs granted provisional approval under this section. Such report shall include— (A) the number of patients treated with each such drug, and the number of patients tracked in an observational registry with respect to each such drug; (B) a discussion of the minimum amount of data required in the registries, including patient treatments and uses, length of use, side effects encountered, relevant biomarkers or scientifically substantiated surrogates, scan results, cause of death and how long the patient lived, and adverse drug effects; (C) a list of all such drugs for which an application for approval under section 505 of this Act or section 351 of the Public Health Service Act, or an application for an extension of provisional approval under this section, has been submitted