【導(dǎo)讀】SECTION1.<<NOTE:21USC301note.>>SHORTTITLE.Sec.1.Shorttitle.Sec.101.Shorttitle;referencesintitle;finding.Sec.201.Shorttitle;referencesintitle;finding.safetyinformation.notification.damage.availability.advisorymittee.

　　

【正文】 d 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。. (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 ``(II) the amount of the total appropriations expended for the process for the review of human drug applications at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) exceeds the amount of appropriations expended for the process for the review of human drug applications at 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). ``(ii) Amount of amount determined in this clause is the lesser of ``(I) the amount equal to the sum of the amounts that, for each of fiscal years 2021 and 2021, is the lesser of ``(aa) the excess amount described in clause (i)(II) for such fiscal year。 or ``(bb) the amount specified in subsection (b)(4)(B)(ii) for such fiscal year。 or ``(II) $65,000,000. ``(iii) ``(I) Fiscal year making the determination under clause (ii), an amount described in subclause (I) of such clause for fiscal year 2021 or 2021 shall be taken into account [[Page 121 STAT. 831]] only if subclauses (I) and (II) of clause (i) apply to such fiscal year. ``(II) Relation to subparagraph (A).The Secretary shall limit any decrease under this paragraph if such a limitation is necessary to provide for the 3 months of operating reserves described in subparagraph (A).39。39。. (5) (5) of section 736(c) (21 . 379h(c)), as redesignated by paragraph (3)(A), is amended by striking ``202139。39。 and insert