Sec. 204. REAUTHORIZATION; REPORTING REQUIREMENTS
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## SEC. 204 REAUTHORIZATION; REPORTING REQUIREMENTS ###
(a)Reauthorization Section 738A(b) (21 U.S.C. 379j-1(b)) is amended— ####
(1)in paragraph (1), by striking “2012” and inserting “2017”; and ####
(2)in paragraph (5), by striking “2012” and inserting “2017”. ###
(b)Performance Reports Section 738A(a) (21 U.S.C. 379j-1(a)) is amended— ####
(1)by striking paragraph
(1)and inserting the following: > > #### “(1) Performance report > > > ##### “(A) In general > > Beginning with fiscal year 2013, for each fiscal year for which fees are collected under this part, 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 annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2012 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. > > > ##### “(B) Publication > > With regard to information to be reported by the Food and Drug Administration to industry on a quarterly and annual basis pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments Act of 2012, the Secretary shall make such information publicly available on the Internet Web site of the Food and Drug Administration not later than 60 days after the end of each quarter or 120 days after the end of each fiscal year, respectively, to which such information applies. This information shall include the status of the independent assessment identified in the letters described in such section 201(b). > > > ##### “(C) Updates > > The Secretary shall include in each report under subparagraph
(A)information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.” > ; and ####
(2)in paragraph (2), by striking “2008 through 2012” and inserting “2013 through 2017”.
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Sec. 204
REAUTHORIZATION; REPORTING REQUIREMENTS
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