Sec. 104. REAUTHORIZATION; REPORTING REQUIREMENTS
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## SEC. 104 REAUTHORIZATION; REPORTING REQUIREMENTS Section 736B (21 U.S.C. 379h-2) is amended— ####
(1)by amending subsection
(a)to read as follows: > > ### “(a) Performance Report > > > #### “(1) In general > > Beginning with fiscal year 2013, not later than 120 days after the end of each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning— > > > ##### “(A) > > the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, including the status of the independent assessment described in such letters; and > > > ##### “(B) > > the progress of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research in achieving the goals, and future plans for meeting the goals, including, for each review division— > > > ###### “(i) > > the number of original standard new drug applications and biologics license applications filed per fiscal year for each review division; > > > ###### “(ii) > > the number of original priority new drug applications and biologics license applications filed per fiscal year for each review division; > > > ###### “(iii) > > the number of standard efficacy supplements filed per fiscal year for each review division; > > > ###### “(iv) > > the number of priority efficacy supplements filed per fiscal year for each review division; > > > ###### “(v) > > the number of applications filed for review under accelerated approval per fiscal year for each review division; > > > ###### “(vi) > > the number of applications filed for review as fast track products per fiscal year for each review division; > > > ###### “(vii) > > the number of applications filed for orphan-designated products per fiscal year for each review division; and > > > ###### “(viii) > > the number of breakthrough designations for a fiscal year for each review division. > > > #### “(2) Inclusion > > The report under this subsection for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all human drug applications and supplements in the cohort.” > . ####
(2)in subsection (b), by striking “2008” and inserting “2013”; and ####
(3)in subsection (d), by striking “2012” each place it appears and inserting “2017”.
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Sec. 104
REAUTHORIZATION; REPORTING REQUIREMENTS
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