not a private foundation (as defined in section 509(a) of such Code) that offers patient assistance. (2) Manufacturer patient assistance program The term manufacturer patient assistance program means an organization, including a private foundation (as so defined), that is sponsored by, or receives funding from, a manufacturer and that offers patient assistance. Such term does not include an independent charity patient assistance program. (3) Patient assistance The term patient assistance means assistance provided to offset the cost of drugs for individuals. Such term includes free products, coupons, rebates, copay or discount cards, and other means of providing assistance to individuals related to drug costs, as determined by the Secretary. (b) Reporting on domestic sales An applicable manufacturer of an approved drug (including a drug approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act and a biological product licensed under subsection (a) or (k) of section 351 of this Act) shall submit to the Secretary and to Congress an annual report, in such format as the Secretary shall require, outlining with respect to the previous calendar year (except as provided in subsection (c)(3))— (1) with respect to each such drug— (A) the total expenditures of the manufacturer on— (i) domestic and foreign drug research and development, including an itemized description of— (I) basic and preclinical research