【正文】 39。39。 or ``(bb) the amount specified in subsection (b)(4)(B)(ii) for such fiscal year。. (4) Final year (4) of section 736(c) (21 . 379h(c)), as redesignated by paragraph (3)(A), is amended to read as follows: [[Page 121 STAT. 830]] ``(4) Final year ``(A) Increase in fiscal year 2021, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), 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 2021. 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 2021. If the Secretary has carryover balances for such process in excess of 3 months of such operating reserves, the adjustment under this subparagraph shall not be made. ``(B) Decrease in ``(i) In fiscal year 2021, the Secretary may, in addition to adjustments under this paragraph and paragraphs (1), (2), and (3), decrease the fee revenues and fees established in subsection (b) by the amount determined in clause (ii), if, for fiscal year 2021 or 2021 ``(I) the amount of the total appropriations for the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of the total appropriations for the Food and Drug Administration for fiscal year 2021 (excluding the amount of fees appropriated for such fiscal year), adjusted as provided under paragraph (1)。 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 established in subsection (b) if actual costs paid for rent and rentrelated expenses for the preceding fiscal year are less than estimates made for such year in fiscal year 2021. Any reduction made under this paragraph shall not exceed the amount by which such costs fall below the estimates made in fiscal year 2021 for such fiscal year, and shall not exceed $11,721,000 for any fiscal year.39。39。39。39。39。39。39。39。39。39。39。39。39。 at the end。 (B) in subparagraph (A), by striking ``or39。 and inserting ``For fiscal year 2021 and subsequent fiscal years, the revenues established in subsection (b)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。 and ``(V) for fiscal year 2021, $65,000,000.39。 ``(III) for fiscal year 2021, $45,000,000。 plus ``(ii)(I) for fiscal year 2021, $25,000,000。 and ``(C) onethird shall be derived from fees under subsection (a)(3) (relating to prescription drug products). ``(3) Modified workload adjustment factor for fiscal year purposes of paragraph (1)(B), the Secretary shall determine the modified workload adjustment factor by determining the dollar amount that results from applying the methodology that was in effect under subsection (c)(2) for fiscal year 2021 to the amount $354,893,000, except that, with respect to the portion of such determination that is based on the change in the total number of mercial investigational 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。 and [[Page 121 STAT. 828]] ``(B) an amount equal to the modified workload adjustment factor for fiscal year 2021 (as determined under paragraph (3)). ``(2) Types of the total revenue amount determined for a fiscal year under paragraph (1) ``(A) onethird shall be derived from fees under