【正文】
vestigational new drug applications, the Secretary shall count the number of such applications that were active during the most recent 12month period for which data on such submissions is available. ``(4) Additional fee revenues for drug ``(A) In NOTE: Applicability. each of the fiscal years 2021 through 2021, paragraph (1)(A) shall be applied by substituting the amount determined under subparagraph (B) for `$392,783,00039。. ``(B) Amount each of the fiscal years 2021 through 2021, the amount determined under this subparagraph is the sum of ``(i) $392,783,000。 plus ``(ii)(I) for fiscal year 2021, $25,000,000。 ``(II) for fiscal year 2021, $35,000,000。 ``(III) for fiscal year 2021, $45,000,000。 ``(IV) for fiscal year 2021, $55,000,000。 and ``(V) for fiscal year 2021, $65,000,000.39。39。. (c) Adjustments to (1) Inflation 736(c)(1) (21 . 379h(c)(1)) is amended (A) in the matter preceding subparagraph (A), by striking ``The revenues established in subsection (b)39。39。 and inserting ``For fiscal year 2021 and subsequent fiscal years, the revenues established in subsection (b)39。39。 (B) in subparagraph (A), by striking ``or39。39。 at the end。 (C) in subparagraph (B), by striking the period at the end and inserting ``, or39。39。 (D) by inserting after subparagraph (B) the following: ``(C) the average annual change in the cost, per fulltime equivalent position of the Food and Drug Administration, of all personnel pensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.39。39。 and (E) in the matter following subparagraph (C) (as added by subparagraph (D)), by striking ``fiscal year 202139。39。 and inserting ``fiscal year 202139。39。. [[Page 121 STAT. 829]] (2) Workload 736(c)(2) (21 . 379h(c)(2)) is amended (A) in the matter preceding subparagraph (A), by striking ``Beginning with fiscal year 2021,39。39。 and inserting ``For fiscal year 2021 and subsequent fiscal years,39。39。 (B) in subparagraph (A), in the first sentence (i) by striking ``human drug applications,39。39。 and inserting ``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),39。39。 (ii) by striking ``mercial investigational new drug applications,39。39。 and (iii) by inserting before the period the following: ``, and the change in the total number of active mercial investigational new drug applications (adjusted for changes in review activities, as so described) during the most recent 12month period for which data on such submissions is available39。39。 (C) in subparagraph (B), by adding at the end the following: ``Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2021 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.39。39。 and (D) by adding at the end the following: ``(C) The NOTE: Contracts. Study. Secretary shall contract with an independent accounting firm to study the adjustment for changes in review activities applied in setting fees and revenue amounts for fiscal year 2021 and to make remendations, if warranted, for future changes in the methodology for calculating the adjustment. NOTE: Effective date. After review of the remendations, the Secretary shall, if warranted, make appropriate changes to the methodology, and the changes shall be effective for each of the fiscal years 2021 through 2021. The Secretary shall not make any adjustment for changes in review activities for any fiscal year after 2021 unless such study has been pleted.39。39。. (3) Rent and rentrelated cost 736(c) (21 . 379h(c)) is amended (A) by redesignating paragraphs (3), (4), and (5) as paragraphs (4), (5), and (6), respectively。 and (B) by inserting after paragraph (2) the following: ``(3) Rent and rentrelated cost fiscal year 2021 and each subsequent fiscal year, the Secretary shall, before making adjustments under paragraphs (1) and (2), decrease the fee revenue amount establishe