of the initial meeting held under section 302(e), the Board shall issue final regulations to carry out this Act. (b) Notice and comment requirement The regulations developed under subsection (a) shall be issued in accordance with the notice and comment procedures established under section 553 of title 5, United States Code. 307. Report to Federal agencies Not later than 1 year after the effective date of the regulations under section 306 and annually thereafter, the Board shall submit to each Federal agency that dispenses or makes payments for the dispensing of prescription drugs or medical devices a report containing a list of each prescription drug and medical device for which an excessive price was charged during the preceding calendar year, as determined by the Board under section 303. The Secretary shall make this report publicly available. 308. Definitions In this title: (1) Affiliate 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) Average manufacturer price 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) Medical device 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) Prescription drug 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) ). (5) Manufacturer The term manufacturer means the person— (A) that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or the license issued under section 351 of the Public Health Service Act