ADDITIONAL REPORTING REQUIREMENTS.

SEC. 408. [21 U.S.C. 379d-4] ADDITIONAL REPORTING REQUIREMENTS. Section 715, as added by section 308 of this Act, is amended by adding at the end the following: “(b) Biosimilar Biological Products. “(1) In general. Beginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under part 8 of subchapter C, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report concerning— “(A) the number of applications for approval filed under section 351(k) of the Public Health Service Act; and “(B) the percentage of applications described in subparagraph (A) that were approved by the Secretary. “(2) Additional information. As part of the performance report described in paragraph (1), the Secretary shall include an explanation of how the Food and Drug Administration is managing the biological product review program to ensure that the user fees collected under part 2 are not used to review an application under section 351(k) of the Public Health Service Act.” .