Reporting requirements

21 U.S.C. § 379d–4
in effect
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(a) Generic drugsBeginning with fiscal year 2013 and ending after fiscal year 2017, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 7 of part 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, for all applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year—(1) the number of such applications that met the goals identified for purposes of subpart 7 of part C, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record; (2) the average total time to decision by the Secretary for applications for approval of a generic drug under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications filed in the previous fiscal year, including the number of calendar days spent during the review by the Food and Drug Administration and the number of calendar days spent by the sponsor responding to a complete response letter; (3) the total number of applications under section 355(j) of this title, amendments to such applications, and prior approval supplements with respect to such applications that were pending with the Secretary for more than 10 months on July 9, 2012; and (4) the number of applications described in paragraph (3) on which the Food and Drug Administration took final regulatory action in the previous fiscal year. (b) Biosimilar biological products(1) In generalBeginning with fiscal year 2014, not later than 120 days after the end of each fiscal year for which fees are collected under subpart 8 of part 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 262(k) of title 42; and (B) the percentage of applications described in subparagraph (A) that were approved by the Secretary. (2) Additional informationAs 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 subpart 2 11 So in original. Probably means subpart 2 of part C. are not used to review an application under section 262(k) of title 42.

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