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) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended— ####
(1)in paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”; and ####
(2)in paragraph (2)— #####
(A)in subparagraph (A)— ######
(i)in the matter preceding clause (i), by striking “October 1, 2012” and inserting “October 1, 2017”; ######
(ii)in clause (viii), by striking “2” and inserting “3.4”; and ######
(iii)by adding at the end the following new clause: > > ###### “(xi) > > For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).” > ; and #####
(B)in subparagraph (B)(v)(I), by striking “or premarket notification submission” and inserting “premarket notification submission, or de novo classification request”. ###
(b)Fee Amounts Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows: > > ### “(b) Fee Amounts > > > #### “(1) In general > > Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, 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 2018Fiscal Year 2019Fiscal Year 2020Fiscal Year 2021Fiscal Year 2022Premarket Application$294,000$300,000$310,000$328,000$329,000Establishment Registration$4,375$4,548$4,760$4,975$4,978 > > > #### “(3) Total revenue amounts specified > > For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: > > > ##### “(A) > > $183,280,756 for fiscal year 2018. > > > ##### “(B) > > $190,654,875 for fiscal year 2019. > > > ##### “(C) > > $200,132,014 for fiscal year 2020. > > > ##### “(D) > > $211,748,789 for fiscal year 2021. > > > ##### “(E) > > $213,687,660 for fiscal year 2022.” > . ###
(c)Annual Fee Setting; Adjustments Section 738(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended— ####
(1)in paragraph (1), by striking “2012” and inserting “2017”; ####
(2)in paragraph (2)— #####
(A)in subparagraph (A), by striking “2014” and inserting “2018”; #####
(B)by striking subparagraph
(B)and inserting the following new subparagraph: > > ##### “(B) Applicable inflation adjustment > > The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is 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 2016.” > ; #####
(C)in subparagraph (C), in the heading, by striking “to total revenue amounts”; and #####
(D)by amending subparagraph
(D)to read as follows: > > ##### “(D) Adjustment to base fee amounts > > For each of fiscal years 2018 through 2022, the Secretary shall— > > > ###### “(i) > > adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph
(B)for such year; and > > > ###### “(ii) > > if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).” > ; and ####
(3)in paragraph (3)— #####
(A)by striking “2014 through 2017” and inserting “2018 through 2022”; and #####
(B)by striking “further adjusted” and inserting “increased”. ###
(d)Small Businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval Fees Section 738(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is amended— ####
(1)in paragraph (1), by striking “specified in clauses
(i)through
(v)and clauses (vii), (ix), and (x)” and inserting “specified in clauses
(i)through
(vii)and clauses (ix), (x), and (xi)”; and ####
(2)in paragraph (2)(C)— #####
(A)by striking “supplement, or” and inserting “supplement,”; and #####
(B)by inserting “, or a de novo classification request” after “class III device”. ###
(e)Small Businesses; Fee Reduction Regarding Premarket Notification Submissions Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking “50” and inserting “25”. ###
(f)Fee Waiver or Reduction ####
(1)Repeal Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection (f). ####
(2)Conforming amendments #####
(A)Section 515(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by striking “738(h)” and inserting “738(g)”. #####
(B)Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by paragraph (1), is further amended— ######
(i)by redesignating subsections
(g)through
(l)as subsections
(f)through (k); ######
(ii)in subsection (a)(2)(A), by striking “(d), (e), and (f)” and inserting “(d) and (e)”; and ######
(iii)in subsection (a)(3)(A), by striking “and subsection (f)”. ###
(g)Effect of Failure To Pay Fees Subsection (f)(1), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— ####
(1)by striking “or periodic reporting concerning a class III device” and inserting “periodic reporting concerning a class III device, or de novo classification request”; and ####
(2)by striking “all fees” and inserting “all such fees”. ###
(h)Conditions Subsection (g)(1)(A), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking “$280,587,000” and inserting “$320,825,000”. ###
(i)Crediting and Availability of Fees Subsection (h), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— ####
(1)in paragraph (3)— #####
(A)by striking “2013 through 2017” and inserting “2018 through 2022”; and #####
(B)by striking “subsection (c)” and all that follows through the period at the end and inserting “subsection (c).”; and ####
(2)by striking paragraph (4).
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