; (2) recommendations to the Federal agency against dispensing or making payments for the dispensing of the prescription drug or medical device; and (3) recommendations to the Federal agency to substitute, in place of any drug or device listed pursuant to paragraph (1), a similar prescription drug or medical device that is not sold at an excessive price. 10. Report to Congress Not later than 1 year after the initial meeting of the Board under section 3(e), and annually thereafter, the Board shall submit to the Congress a report describing the activities of the Board for the preceding year. 11. Definitions In this Act: (1) The term affiliate means, with respect to a manufacturer, any entity that controls, is controlled by, or is under common control with such manufacturer. (2) The term average manufacturer price means the average price charged by the manufacturer of a prescription drug or medical device, as applicable, for sales of the drug or device by the manufacturer in the United States over the respective annual quarter. (3) The term medical device means a device (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )). (4) The term prescription drug means a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 )) that is subject to section 503(b)(1) of such Act ( 21 U.S.C. 353(b)(1) ).