Sec. 103. AUTHORITY TO ASSESS AND USE DRUG FEES
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## SEC. 103 AUTHORITY TO ASSESS AND USE DRUG FEES Section 736 (21 U.S.C. 379h) is amended— ####
(1)in subsection (a)— #####
(A)in the matter preceding paragraph (1), by striking “fiscal year 2008” and inserting “fiscal year 2013”; #####
(B)in paragraph (1)(A)— ######
(i)in clause (i), by striking “(c)(5)” and inserting “(c)(4)”; and ######
(ii)in clause (ii), by striking “(c)(5)” and inserting “(c)(4)”; #####
(C)in the matter following clause
(ii)in paragraph (2)(A)— ######
(i)by striking “(c)(5)” and inserting “(c)(4)”; and ######
(ii)by striking “payable on or before October 1 of each year” and inserting “due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section”; #####
(D)in paragraph (3)— ######
(i)in subparagraph (A)— ######
(I)by striking “subsection (c)(5)” and inserting “subsection (c)(4)”; and ######
(II)by striking “payable on or before October 1 of each year.” and inserting “due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section.”; and ######
(ii)by amending subparagraph
(B)to read as follows: > > ##### “(B) Exception > > A prescription drug product shall not be assessed a fee under subparagraph
(A)if such product is— > > > ###### “(i) > > identified on the list compiled under section 505(j)(7) with a potency described in terms of per 100 mL; > > > ###### “(ii) > > the same product as another product that— > > > ###### “(I) > > was approved under an application filed under section 505(b) or 505(j); and > > > ###### “(II) > > is not in the list of discontinued products compiled under section 505(j)(7); > > > ###### “(iii) > > the same product as another product that was approved under an abbreviated application filed under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997); or > > > ###### “(iv) > > the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.” > ; ####
(2)in subsection (b)— #####
(A)in paragraph (1)— ######
(i)in the matter preceding subparagraph (A), by striking “fiscal years 2008 through 2012” and inserting “fiscal years 2013 through 2017”; ######
(ii)in subparagraph (A), by striking “$392,783,000; and” and inserting “$693,099,000;”; and ######
(iii)by striking subparagraph
(B)and inserting the following: > > ##### “(B) > > the dollar amount equal to the inflation adjustment for fiscal year 2013 (as determined under paragraph (3)(A)); and > > > ##### “(C) > > the dollar amount equal to the workload adjustment for fiscal year 2013 (as determined under paragraph (3)(B)).” > ; and #####
(B)by striking paragraphs
(3)and
(4)and inserting the following: > > #### “(3) Fiscal year 2013 inflation and workload adjustments > > For purposes of paragraph (1), the dollar amount of the inflation and workload adjustments for fiscal year 2013 shall be determined as follows: > > > ##### “(A) Inflation adjustment > > The inflation adjustment for fiscal year 2013 shall be the sum of— > > > ###### “(i) > > $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(B); and > > > ###### “(ii) > > $652,709,000 multiplied by the result of an inflation adjustment calculation determined using the methodology described in subsection (c)(1)(C). > > > ##### “(B) Workload adjustment > > Subject to subparagraph (C), the workload adjustment for fiscal 2013 shall be— > > > ###### “(i) > > $652,709,000 plus the amount of the inflation adjustment calculated under subparagraph (A); multiplied by > > > ###### “(ii) > > the amount (if any) by which a percentage workload adjustment for fiscal year 2013, as determined using the methodology described in subsection (c)(2)(A), would exceed the percentage workload adjustment (as so determined) for fiscal year 2012, if both such adjustment percentages were calculated using the 5-year base period consisting of fiscal years 2003 through 2007. > > > ##### “(C) Limitation > > Under no circumstances shall the adjustment under subparagraph
(B)result in fee revenues for fiscal year 2013 that are less than the sum of the amount under paragraph (1)(A) and the amount under paragraph (1)(B).” > ; ####
(3)by striking subsection
(c)and inserting the following: > > ### “(c) Adjustments > > > #### “(1) Inflation adjustment > > For fiscal year 2014 and subsequent fiscal years, the revenues established in subsection
(b)shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year by the amount equal to the sum of— > > > ##### “(A) > > one; > > > ##### “(B) > > the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years, and > > > ##### “(C) > > the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years. > > The adjustment made each fiscal year under this paragraph shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2013 under this paragraph. > > > #### “(2) Workload adjustment > > For fiscal year 2014 and subsequent fiscal years, after the fee revenues established in subsection
(b)are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of human drug applications. With respect to such adjustment: > > > ##### “(A) > > The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12-month period for which data on such submissions is available. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies. > > > ##### “(B) > > Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the sum of the amount under subsection (b)(1)(A) and the amount under subsection (b)(1)(B), as adjusted for inflation under paragraph (1). > > > ##### “(C) > > The Secretary shall contract with an independent accounting or consulting firm to periodically review the adequacy of the adjustment and publish the results of those reviews. The first review shall be conducted and published by the end of fiscal year 2013 (to examine the performance of the adjustment since fiscal year 2009), and the second review shall be conducted and published by the end of fiscal year 2015 (to examine the continued performance of the adjustment). The reports shall evaluate whether the adjustment reasonably represents actual changes in workload volume and complexity and present options to discontinue, retain, or modify any elements of the adjustment. The reports shall be published for public comment. After review of the reports and receipt of public comments, the Secretary shall, if warranted, adopt appropriate changes to the methodology. If the Secretary adopts changes to the methodology based on the first report, the changes shall be effective for the first fiscal year for which fees are set after the Secretary adopts such changes and each subsequent fiscal year. > > > #### “(3) Final year adjustment > > For fiscal year 2017, the Secretary may, in addition to adjustments under this paragraph and paragraphs
(1)and (2), further increase the fee revenues and fees established in subsection
(b)if such an adjustment is necessary to provide for not more than 3 months of operating reserves of carryover user fees for the process for the review of human drug applications for the first 3 months of fiscal year 2018. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2017. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this paragraph shall not be made. > > > #### “(4) Annual fee setting > > The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2012, establish, for the next fiscal year, application, product, and establishment fees under subsection (a), based on the revenue amounts established under subsection
(b)and the adjustments provided under this subsection. > > > #### “(5) Limit > > The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.” > ; and ####
(4)in subsection (g)— #####
(A)in paragraph (1), by striking “Fees authorized” and inserting “Subject to paragraph (2)(C), fees authorized”; #####
(B)in paragraph (2)— ######
(i)in subparagraph (A)(i), by striking “shall be retained” and inserting “subject to subparagraph (C), shall be collected and available”; ######
(ii)in subparagraph (A)(ii), by striking “shall only be collected and available” and inserting “shall be available”; and ######
(iii)by adding at the end the following new subparagraph: > > ##### “(C) Provision for early payments > > Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.” > ; #####
(C)in paragraph (3), by striking “fiscal years 2008 through 2012” and inserting “fiscal years 2013 through 2017”; and #####
(D)in paragraph (4)— ######
(i)by striking “fiscal years 2008 through 2010” and inserting “fiscal years 2013 through 2015”; ######
(ii)by striking “fiscal year 2011” and inserting “fiscal year 2016”; ######
(iii)by striking “fiscal years 2008 through 2011” and inserting “fiscal years 2013 through 2016”; and ######
(iv)by striking “fiscal year 2012” and inserting “fiscal year 2017”.
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Sec. 103
AUTHORITY TO ASSESS AND USE DRUG FEES
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