H. R. 6833—44 
shall only be the workload categories specified in sec-
tion VIII.B.2.e. of the letters described in section 
3001(b) of the Generic Drug User Fee Amendments 
of 2022. 
‘‘(C) LIMITATIONS.— 
‘‘(i) IN GENERAL.—Under no circumstances shall 
an adjustment under this paragraph result in fee rev-
enue for a fiscal year that is less than the sum of 
the amounts under subsection (b)(1)(B)(ii) (the base 
revenue amount for the fiscal year) and paragraph 
(1) (the dollar amount of the inflation adjustment for 
the fiscal year). 
‘‘(ii) 
ADDITIONAL
LIMITATION.—An 
adjustment 
under this paragraph shall not exceed 3 percent of 
the sum described in clause (i) for the fiscal year, 
except that such limitation shall be 4 percent if— 
‘‘(I) for purposes of a fiscal year 2024 adjust-
ment, the Secretary determines that during the 
period from April 1, 2021, through March 31, 
2023— 
‘‘(aa) the total number of abbreviated new 
drug applications submitted was greater than 
or equal to 2,000; or 
‘‘(bb) thirty-five percent or more of abbre-
viated 
new 
drug 
applications 
submitted 
related to complex products (as that term is 
defined in section XI of the letters described 
in section 3001(b) of the Generic Drug User 
Fee Amendments of 2022); 
‘‘(II) for purposes of a fiscal year 2025 adjust-
ment, the Secretary determines that during the 
period from April 1, 2022, through March 31, 
2024— 
‘‘(aa) the total number of abbreviated new 
drug applications submitted was greater than 
or equal to 2,300; or 
‘‘(bb) thirty-five percent or more of abbre-
viated 
new 
drug 
applications 
submitted 
related to complex products (as so defined); 
‘‘(III) for purposes of a fiscal year 2026 adjust-
ment, the Secretary determines that during the 
period from April 1, 2023, through March 31, 
2025— 
‘‘(aa) the total number of abbreviated new 
drug applications submitted was greater than 
or equal to 2,300; or 
‘‘(bb) thirty-five percent or more of abbre-
viated 
new 
drug 
applications 
submitted 
related to complex products (as so defined); 
and 
‘‘(IV) for purposes of a fiscal year 2027 adjust-
ment, the Secretary determines that during the 
period from April 1, 2024, through March 31, 
2026— 
‘‘(aa) the total number of abbreviated new 
drug applications submitted was greater than 
or equal to 2,300; or
H. R. 6833—45 
‘‘(bb) thirty-five percent or more of abbre-
viated 
new 
drug 
applications 
submitted 
related to complex products (as so defined). 
‘‘(D) PUBLICATION
IN
FEDERAL
REGISTER.—The Sec-
retary shall publish in the Federal Register notice referred 
to in subsection (a) the fee revenue and fees resulting 
from the adjustment and the methodology under this para-
graph. 
‘‘(3) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2024 and each subse-
quent fiscal year, the Secretary may, in addition to adjust-
ments under paragraphs (1) and (2), further increase the 
fee revenue and fees under this section for such fiscal 
year if such an adjustment is necessary to provide operating 
reserves of carryover user fees for human generic drug 
activities for not more than the number of weeks specified 
in subparagraph (B) with respect to that fiscal year. 
‘‘(B) NUMBER OF WEEKS.—The number of weeks speci-
fied in this subparagraph is— 
‘‘(i) 8 weeks for fiscal year 2024; 
‘‘(ii) 9 weeks for fiscal year 2025; and 
‘‘(iii) 10 weeks for each of fiscal year 2026 and 
2027. 
‘‘(C) DECREASE.—If the Secretary has carryover bal-
ances for human generic drug activities in excess of 12 
weeks of the operating reserves referred to in subparagraph 
(A), the Secretary shall decrease the fee revenue and fees 
referred to in such subparagraph to provide for not more 
than 12 weeks of such operating reserves. 
‘‘(D) RATIONALE FOR ADJUSTMENT.—If an adjustment 
under this paragraph is made, the rationale for the amount 
of the increase or decrease (as applicable) in fee revenue 
and fees shall be contained in the annual Federal Register 
notice under subsection (a) publishing the fee revenue and 
fees for the fiscal year involved.’’. 
(d) ANNUAL FEE SETTING.—Section 744B(d)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(d)(1)) is 
amended— 
(1) in the paragraph heading, by striking ‘‘2018 THROUGH 
2022’’ and inserting ‘‘2023 THROUGH 2027’’; and 
(2) by striking ‘‘more than 60 days before the first day 
of each of fiscal years 2018 through 2022’’ and inserting ‘‘later 
than 60 days before the first day of each of fiscal years 2023 
through 2027’’. 
(e) EFFECT OF FAILURE TO PAY FEES.—The heading of para-
graph (3) of section 744B(g) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–42(g)) is amended by striking ‘‘AND
PRIOR 
APPROVAL SUPPLEMENT FEE’’. 
(f) CREDITING AND AVAILABILITY OF FEES.—Section 744B(i)(3) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
42(i)(3)) is amended by striking ‘‘fiscal years 2018 through 2022’’ 
and inserting ‘‘fiscal years 2023 through 2027’’. 
SEC. 3003. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 744C of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–43) is amended—
H. R. 6833—46 
(1) in subsection (a)(1), by striking ‘‘Beginning with fiscal 
year 2018, not’’ and inserting ‘‘Not’’; 
(2) by striking ‘‘Generic Drug User Fee Amendments of 
2017’’ each place it appears and inserting ‘‘Generic Drug User 
Fee Amendments of 2022’’; 
(3) in subsection (a)(2), by striking ‘‘Not later than 30 
calendar days after the end of the second quarter of fiscal 
year 2018, and not later than 30 calendar days after the end 
of each quarter of each fiscal year thereafter’’ and inserting 
‘‘Not later than 30 calendar days after the end of each quarter 
of each fiscal year for which fees are collected under this 
part’’; 
(4) in subsection (a)(3), by striking ‘‘Beginning with fiscal 
year 2020, the’’ and inserting ‘‘The’’; 
(5) in subsection (b), by striking ‘‘Beginning with fiscal 
year 2018, not’’ and inserting ‘‘Not’’; 
(6) in subsection (c), by striking ‘‘Beginning with fiscal 
year 2018, for’’ and inserting ‘‘For’’; and 
(7) in subsection (f)— 
(A) in paragraph (1), in the matter preceding subpara-
graph (A), by striking ‘‘fiscal year 2022’’ and inserting 
‘‘fiscal year 2027’’; and 
(B) in paragraph (5), by striking ‘‘January 15, 2022’’ 
and inserting ‘‘January 15, 2027’’. 
SEC. 3004. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 744A and 744B of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall 
cease to be effective October 1, 2027. 
(b) REPORTING REQUIREMENTS.—Section 744C of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to 
be effective January 31, 2028. 
(c) PREVIOUS SUNSET PROVISION.—Effective October 1, 2022, 
subsections (a) and (b) of section 305 of the FDA Reauthorization 
Act of 2017 (Public Law 115–52) are repealed. 
SEC. 3005. EFFECTIVE DATE. 
The amendments made by this title shall take effect on October 
1, 2022, or the date of the enactment of this Act, whichever is 
later, except that fees under part 7 of subchapter C of chapter 
VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
41 et seq.) shall be assessed for all abbreviated new drug applica-
tions received on or after October 1, 2022, regardless of the date 
of the enactment of this Act. 
SEC. 3006. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, part 7 
of subchapter C of chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379j–41 et seq.), as in effect on the day 
before the date of the enactment of this title, shall continue to 
be in effect with respect to abbreviated new drug applications 
(as defined in such part as of such day) that were received by 
the Food and Drug Administration within the meaning of section 
505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval 
supplements that were submitted, and drug master files for Type 
II active pharmaceutical ingredients that were first referenced on 
or after October 1, 2017, but before October 1, 2022, with respect