Page:United States Statutes at Large Volume 124.djvu/845

 124 STAT. 819 PUBLIC LAW 111–148—MAR. 23, 2010 Public Health Service Act (as added by this Act) during such period. (C) AUDIT.— (i) IN GENERAL.—On the date that is 2 years after first receiving a user fee applicable to an application for a biological product under section 351(k) of the Public Health Service Act (as added by this Act), and on a biennial basis thereafter until October 1, 2013, the Secretary shall perform an audit of the costs of reviewing such applications under such section 351(k). Such an audit shall compare— (I) the costs of reviewing such applications under such section 351(k) to the amount of the user fee applicable to such applications; and (II)(aa) such ratio determined under subclause (I); to (bb) the ratio of the costs of reviewing applica- tions for biological products under section 351(a) of such Act (as amended by this Act) to the amount of the user fee applicable to such applications under such section 351(a). (ii) ALTERATION OF USER FEE.—If the audit per- formed under clause (i) indicates that the ratios com- pared under subclause (II) of such clause differ by more than 5 percent, then the Secretary shall alter the user fee applicable to applications submitted under such section 351(k) to more appropriately account for the costs of reviewing such applications. (iii) ACCOUNTING STANDARDS.—The Secretary shall perform an audit under clause (i) in conformance with the accounting principles, standards, and requirements prescribed by the Comptroller General of the United States under section 3511 of title 31, United State Code, to ensure the validity of any potential variability. (4) AUTHORIZATION OF APPROPRIATIONS.—There is author- ized to be appropriated to carry out this subsection such sums as may be necessary for each of fiscal years 2010 through 2012. (g) PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS.— (1) IN GENERAL.—Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following: ‘‘(m) PEDIATRIC STUDIES.— ‘‘(1) APPLICATION OF CERTAIN PROVISIONS.—The provisions of subsections (a), (d), (e), (f), (i), (j), (k), (l), (p), and (q) of section 505A of the Federal Food, Drug, and Cosmetic Act shall apply with respect to the extension of a period under paragraphs (2) and (3) to the same extent and in the same manner as such provisions apply with respect to the extension of a period under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act. ‘‘(2) MARKET EXCLUSIVITY FOR NEW BIOLOGICAL PROD- UCTS.—If, prior to approval of an application that is submitted under subsection (a), the Secretary determines that information relating to the use of a new biological product in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies Determination. Time period.