Page:United States Statutes at Large Volume 124.djvu/886

 124 STAT. 860 PUBLIC LAW 111–148—MAR. 23, 2010 (3) SECRETARIAL DETERMINATION.—The Secretary of the Treasury shall calculate the amount of each covered entity’s fee for any calendar year under paragraph (1). In calculating such amount, the Secretary of the Treasury shall determine such covered entity’s branded prescription drug sales on the basis of reports submitted under subsection (g) and through the use of any other source of information available to the Secretary of the Treasury. (c) TRANSFER OF FEES TO MEDICARE PART B TRUST FUND.— There is hereby appropriated to the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of the Social Security Act an amount equal to the fees received by the Secretary of the Treasury under subsection (a). (d) COVERED ENTITY.— (1) IN GENERAL.—For purposes of this section, the term ‘‘covered entity’’ means any manufacturer or importer with gross receipts from branded prescription drug sales. (2) CONTROLLED GROUPS.— (A) IN GENERAL.—For purposes of this subsection, all persons treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 or subsection (m) or (o) of section 414 of such Code shall be treated as a single covered entity. (B) INCLUSION OF FOREIGN CORPORATIONS.—For pur- poses of subparagraph (A), in applying subsections (a) and (b) of section 52 of such Code to this section, section 1563 of such Code shall be applied without regard to subsection (b)(2)(C) thereof. (e) BRANDED PRESCRIPTION DRUG SALES.—For purposes of this section— (1) IN GENERAL.—The term ‘‘branded prescription drug sales’’ means sales of branded prescription drugs to any speci- fied government program or pursuant to coverage under any such program. (2) BRANDED PRESCRIPTION DRUGS.— (A) IN GENERAL.—The term ‘‘branded prescription drug’’ means— (i) any prescription drug the application for which was submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)), or (ii) any biological product the license for which was submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)). (B) PRESCRIPTION DRUG.—For purposes of subpara- graph (A)(i), the term ‘‘prescription drug’’ means any drug which is subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)). (3) EXCLUSION OF ORPHAN DRUG SALES.—The term ‘‘branded prescription drug sales’’ shall not include sales of any drug or biological product with respect to which a credit was allowed for any taxable year under section 45C of the Internal Revenue Code of 1986. The preceding sentence shall not apply with respect to any such drug or biological product after the date on which such drug or biological product is approved by the Food and Drug Administration for marketing for any indication other than the treatment of the rare disease or condition with respect to which such credit was allowed. Definitions. Applicability. Definition.