Sec. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES
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## SEC. 203 AUTHORITY TO ASSESS AND USE DEVICE FEES ###
(a)Types of Fees Section 738(a) (21 U.S.C. 379j(a)) is amended— ####
(1)in paragraph (1), by striking “fiscal year 2008” and inserting “fiscal year 2013”; ####
(2)in paragraph (2)(A)— #####
(A)in the matter preceding clause (i)— ######
(i)by striking “subsections
(d)and (e)” and inserting “subsections (d), (e), and (f)”; ######
(ii)by striking “October 1, 2002” and inserting “October 1, 2012”; and ######
(iii)by striking “subsection (c)(1)” and inserting “subsection (c)”; and #####
(B)in clause (viii), by striking “1.84” and inserting “2”; and ####
(3)in paragraph (3)— #####
(A)in subparagraph (A), by inserting “and subsection (f)” after “subparagraph (B)”; and #####
(B)in subparagraph (C), by striking “ initial registration ” and all that follows through “ section 510. ” and inserting > “later of— > > > ###### “(i) > > the initial or annual registration (as applicable) of the establishment under section 510; or > > > ###### “(ii) > > the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.” > . ###
(b)Fee Amounts Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows: > > ### “(b) Fee Amounts > > > #### “(1) In general > > Subject to subsections (c), (d), (e), (f), and (i), for each of fiscal years 2013 through 2017, fees under subsection
(a)shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3). > > > #### “(2) Base fee amounts specified > > For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: ``Fee TypeFiscal Year 2013Fiscal Year 2014Fiscal Year 2015Fiscal Year 2016Fiscal Year 2017Premarket Application$248,000$252,960$258,019$263,180$268,443Establishment Registration$2,575$3,200$3,750$3,872$3,872 > > > #### “(3) Total revenue amounts specified > > For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: > > > ##### “(A) > > $97,722,301 for fiscal year 2013. > > > ##### “(B) > > $112,580,497 for fiscal year 2014. > > > ##### “(C) > > $125,767,107 for fiscal year 2015. > > > ##### “(D) > > $129,339,949 for fiscal year 2016. > > > ##### “(E) > > $130,184,348 for fiscal year 2017.” > . ###
(c)Annual Fee Setting; Adjustments Section 738(c) (21 U.S.C. 379j(c)) is amended— ####
(1)in the subsection heading, by inserting “; Adjustments” after “Setting”; ####
(2)by striking paragraphs
(1)and (2); ####
(3)by redesignating paragraphs
(3)and
(4)as paragraphs
(4)and (5), respectively; and ####
(4)by inserting before paragraph (4), as so redesignated, the following: > > #### “(1) In general > > The Secretary shall, 60 days before the start of each fiscal year after September 30, 2012, establish fees under subsection (a), based on amounts specified under subsection
(b)and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register. > > > #### “(2) Inflation adjustments > > > ##### “(A) Adjustment to total revenue amounts > > For fiscal year 2014 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph
(B)for such year. > > > ##### “(B) Applicable inflation adjustment to total revenue amounts > > The applicable inflation adjustment for a fiscal year is— > > > ###### “(i) > > for fiscal year 2014, the base inflation adjustment under subparagraph
(C)for such fiscal year; and > > > ###### “(ii) > > for fiscal year 2015 and each subsequent fiscal year, the product of— > > > ###### “(I) > > the base inflation adjustment under subparagraph
(C)for such fiscal year; and > > > ###### “(II) > > the product of the base inflation adjustment under subparagraph
(C)for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014. > > > ##### “(C) Base inflation adjustment to total revenue amounts > > > ###### “(i) In general > > Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus— > > > ###### “(I) > > 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 0.60; and > > > ###### “(II) > > 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 0.40. > > > ###### “(ii) Limitations > > For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)— > > > ###### “(I) > > is less than 1, such adjustment shall be considered to be equal to 1; or > > > ###### “(II) > > is greater than 1.04, such adjustment shall be considered to be equal to 1.04. > > > ##### “(D) Adjustment to base fee amounts > > For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A). > > > #### “(3) Volume-based adjustments to establishment registration base fees > > For each of fiscal years 2014 through 2017, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be further adjusted, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).” > . ###
(d)Fee Waiver or Reduction Section 738 (21 U.S.C. 379j) is amended by— ####
(1)redesignating subsections
(f)through
(k)as subsections
(g)through (l), respectively; and ####
(2)by inserting after subsection
(e)the following new subsection: > > ### “(f) Fee Waiver or Reduction > > > #### “(1) In general > > The Secretary may, at the Secretary’s sole discretion, grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the Secretary finds that such waiver or reduction is in the interest of public health. > > > #### “(2) Limitation > > The sum of all fee waivers or reductions granted by the Secretary in any fiscal year under paragraph
(1)shall not exceed 2 percent of the total fee revenue amounts established for such year under subsection (c). > > > #### “(3) Duration > > The authority provided by this subsection terminates October 1, 2017.” > . ###
(e)Conditions Section 738(h)(1)(A) (21 U.S.C. 379j(h)(1)(A)), as redesignated by subsection (d)(1), is amended by striking “$205,720,000” and inserting “$280,587,000”. ###
(f)Crediting and Availability of Fees Section 738(i) (21 U.S.C. 379j(i)), as redesignated by subsection (d)(1), is amended— ####
(1)in paragraph (1), by striking “Fees authorized” and inserting “Subject to paragraph (2)(C), fees authorized”; ####
(2)in paragraph (2)— #####
(A)in subparagraph (A)— ######
(i)in clause (i), by striking “shall be retained” and inserting “subject to subparagraph (C), shall be collected and available”; and ######
(ii)in clause (ii)— ######
(I)by striking “collected and” after “shall only be”; and ######
(II)by striking “fiscal year 2002” and inserting “fiscal year 2009”; and #####
(B)by adding at the end, the following: > > ##### “(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.” > ; ####
(3)by amending paragraph
(3)to read as follows: > > #### “(3) Authorizations of appropriations > > For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection
(c)and, for fiscal year 2017 only, as further adjusted under paragraph (4).” > ; and ####
(4)in paragraph (4)— #####
(A)by striking “fiscal years 2008, 2009, and 2010” and inserting “fiscal years 2013, 2014, and 2015”; #####
(B)by striking “fiscal year 2011” and inserting “fiscal year 2016”; #####
(C)by striking “June 30, 2011” and inserting “June 30, 2016”; #####
(D)by striking “the amount of fees specified in aggregate in” and inserting “the cumulative amount appropriated pursuant to”; #####
(E)by striking “aggregate amount in” before “excess shall be credited”; and #####
(F)by striking “fiscal year 2012” and inserting “fiscal year 2017”. ###
(g)Conforming Amendment Section 515(c)(4)(A) (21 U.S.C. 360e(c)(4)(A)) is amended by striking “738(g)” and inserting “738(h)”.
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