【正文】 . (5) (5) of section 736(c) (21 . 379h(c)), as redesignated by paragraph (3)(A), is amended by striking ``202139。 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。. (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。 (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。 (ii) by striking ``mercial investigational new drug applications,39。 (B) in subparagraph (A), in the first sentence (i) by striking ``human drug applications,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。 and (E) in the matter following subparagraph (C) (as added by subparagraph (D)), by striking ``fiscal year 202139。 (C) in subparagraph (B), by striking the period at the end and inserting ``, or39。39。39。 ``(II) for fiscal year 2021, $35,000,000。 ``(B) onethird shall be derived from fees under subsection (a)(2) (relating to prescription drug establishments)。 in section 201(ii), except that paragraph (1)(B) of such section shall not apply.39。39。39。 and (ii) by inserting before the period at the end the following: ``or withdrawn without a waiver before filing39。 (2) in paragraph (1) (A) in subparagraph (D) (i) in the heading, by inserting ``or withdrawn before filing39。. SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES. (a) Types of 736(a) (21 . 379h(a)) is amended (1) in the matter preceding paragraph (1), by striking ``202139。 and (8) by inserting after paragraph (8) the following paragraphs: ``(9) The term `person39。39。39。39。39。39。 (C) by redesignating subparagraph (C) as subparagraph (B)。39。39。 REFERENCES IN TITLE。 reporting requirements. Sec. 214. Savings clause. Sec. 215. Additional authorization of appropriations for postmarket safety information. Sec. 216. Effective date. Sec. 217. Sunset clause. Subtitle BAmendments Regarding Regulation of Medical Devices Sec. 221. Extension of authority for third party review of premarket notification. Sec. 222. Registration. Sec. 223. Filing of lists of drugs and devices manufactured, prepared, propagated, and pounded by registrants。 reporting requirements. Sec. 106. Sunset dates. Sec. 107. Effective date. Sec. 108. Savings clause. Sec. 109. Technical amendment。39。. SEC. 2. TABLE OF CONTENTS. The table of contents for this Act is as follows: Sec. 1. Short title. Sec. 2. Table of contents. TITLE IPRESCRIPTION DRUG USER FEE AMENDMENTS OF 2021 Sec. 101. Short title。 conforming amendment. TITLE IIMEDICAL DEVICE USER FEE AMENDMENTS OF 2021 Sec. 201. Short title。 statements。 FINDING. (a) Short NOTE: 21 USC 301 note. title may be cited as the ``Prescription Drug User Fee Amendments of 202139。 and inserting ``For purposes of this part39。 and inserting ``505(b), or39。 and [[Page 121 STAT. 826]] (D) in the matter following subparagraph (B), as so redesignated, by striking ``subparagraph (C)39。