Sec. 203. Authority to assess and use device fees
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Section 738(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(a) ) is amended— in paragraph (1), by striking fiscal year 2013 and inserting fiscal year 2018 ; and in paragraph (2)— in subparagraph (A)— in the matter preceding clause (i), by striking October 1, 2012 and inserting October 1, 2017 ; in clause (viii), by striking 2 and inserting 3.4 ; and by adding at the end the following new clause: For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i). ; and in subparagraph (B)(v)(I), by striking or premarket notification submission and inserting premarket notification submission, or de novo classification request .
Section 738(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(b) ) is amended to read as follows: 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). For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: Fee Type Fiscal Year 2018 Fiscal Year 2019 Fiscal Year 2020 Fiscal Year 2021 Fiscal Year 2022 Premarket Application $294,000 $300,000 $310,000 $328,000 $329,000 Establishment Registration $4,375 $4,548 $4,760 $4,975 $4,978 For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: $183,280,756 for fiscal year 2018. $190,654,875 for fiscal year 2019. $200,132,014 for fiscal year 2020. $211,748,789 for fiscal year 2021. $213,687,660 for fiscal year 2022. . Section 738(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(c) ) is amended— in paragraph (1), by striking 2012 and inserting 2017 ; in paragraph (2)— in subparagraph (A), by striking 2014 and inserting 2018 ; by striking subparagraph
(B)and inserting the following new subparagraph: The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of— the base inflation adjustment under subparagraph
(C)for such fiscal year; and 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. ; in subparagraph (C), in the heading, by striking ; and to total revenue amounts by amending subparagraph
(D)to read as follows: For each of fiscal years 2018 through 2022, the Secretary shall— 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 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 in paragraph (3)— by striking 2014 through 2017 and inserting 2018 through 2022 ; and by striking further adjusted and inserting increased . Section 738(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j(d) ) is amended— 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 in paragraph (2)(C)— by striking supplement, or and inserting supplement, ; and by inserting , or a de novo classification request after class III device . 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 . Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ) is amended by striking subsection (f). 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) . Section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ), as amended by paragraph (1), is further amended— by redesignating subsections
(g)through
(l)as subsections
(f)through (k); in subsection (a)(2)(A), by striking (d), (e), and
(f)and inserting
(d)and
(e); and in subsection (a)(3)(A), by striking and subsection
(f). Subsection (f)(1), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ) is amended— 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 by striking all fees and inserting all such fees . 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 . Subsection (h), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j ) is amended— in paragraph (3)— by striking 2013 through 2017 and inserting 2018 through 2022 ; and by striking subsection
(c)and all that follows through the period at the end and inserting subsection (c). ; and by striking paragraph (4).
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