; and (v) total expected expenditures for marketing and advertising for the drug in the first 3 years that the drug is on the market; (D) the anticipated number of patients who will be treated with the drug; (E) a copy of the application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ) and any subsequent information or data requested by, or submitted to, the Food and Drug Administration during the approval process; (F) any additional information requested by the Drug Affordability and Access Committee; and (G) any additional information the manufacturer chooses to provide related to drug pricing decisions; (3) submit the manufacturer list price and retail price of an applicable drug to the Drug Affordability and Access Committee for a reasonable price determination