; (E) pursuing new or expanded indications for such drug through supplemental applications under section 505 of the Federal Food, Drug, and Cosmetic Act; and (F) carrying out postmarket requirements related to such drug, including under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. (6) Total expenditures on domestic and foreign marketing and advertising related to the drug. (7) Investments in human clinical trials related to the drug, by each trial and each year, including grants, research contracts, tax credits or deductions, and reimbursements from public or private health plans or insurance, and any other public sector subsidies or incentives, such as the fair market value or priority review vouchers or other considerations. (8) The estimated size of the affected patient population. (9) Additional information the manufacturer chooses to provide related to drug pricing decisions, such as information related to the methodology used to set the price of the drug. (10) Additional information as the Secretary determines necessary to carry out this Act, including information for previous years. (b) Report due date Applicable manufacturers shall submit the reports described in subsection (a) not later than January 15 of the year following the date of enactment of this Act, and of each year thereafter. (c) Penalty for noncompliance (1) In general Any manufacturer that fails to submit information for a drug as required by this section on a timely basis or that knowingly provides false information shall be liable for a civil monetary penalty, as determined by the Secretary under paragraph (2), in addition to any other penalty under other applicable provisions of law. (2) Amount of penalty The amount of a civil penalty under paragraph (1) shall be equal to the product of— (A) an amount, as determined appropriate by the Secretary, which is— (i) not less than 0.5 percent of the gross revenues from sales for the previous calendar year of the drug for which the information was not submitted