H. R. 6833—50 
list referenced in subparagraph (A) of discontinued 
biosimilar biological products, and on any subsequent 
day during such fiscal year the biosimilar biological 
product does not appear on such list, except as provided 
in subparagraph (D), each person who is named as 
the applicant in a biosimilar biological product applica-
tion with respect to such product shall pay the annual 
biosimilar biological product program fee established 
for a fiscal year under subsection (c)(5) for such bio-
similar biological product. Notwithstanding subpara-
graph (B), such fee shall be due on the last business 
day of such fiscal year and shall be paid only once 
for each such product for each fiscal year.’’. 
(8) BIOSIMILAR BIOLOGICAL PRODUCT FEE.—Section 744H(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52(a)) is amended by striking paragraph (4). 
(b) FEE REVENUE AMOUNTS.—Subsection (b) of section 744H 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
52) is amended— 
(1) by striking paragraph (1); 
(2) by redesignating paragraphs (2) through (4) as para-
graphs (1) through (3), respectively; 
(3) by amending paragraph (1) (as so redesignated) to read 
as follows: 
‘‘(1) IN GENERAL.—For each of the fiscal years 2023 through 
2027, fees under subsection (a) shall, except as provided in 
subsection (c), be established to generate a total revenue 
amount equal to the sum of— 
‘‘(A) the annual base revenue for the fiscal year (as 
determined under paragraph (3)); 
‘‘(B) the dollar amount equal to the inflation adjust-
ment for the fiscal year (as determined under subsection 
(c)(1)); 
‘‘(C) the dollar amount equal to the strategic hiring 
and retention adjustment (as determined under subsection 
(c)(2)); 
‘‘(D) the dollar amount equal to the capacity planning 
adjustment for the fiscal year (as determined under sub-
section (c)(3)); 
‘‘(E) the dollar amount equal to the operating reserve 
adjustment for the fiscal year, if applicable (as determined 
under subsection (c)(4)); 
‘‘(F) for fiscal year 2023 an additional amount of 
$4,428,886; and 
‘‘(G) for fiscal year 2024 an additional amount of 
$320,569.’’; 
(4) in paragraph (2) (as so redesignated)— 
(A) in the paragraph heading, by striking ‘‘; LIMITA-
TIONS ON FEE AMOUNTS’’; 
(B) by striking subparagraph (B); and 
(C) by redesignating subparagraphs (C) and (D) as 
subparagraphs (B) and (C), respectively; and 
(5) by amending paragraph (3) (as so redesignated) to read 
as follows: 
‘‘(3) ANNUAL BASE REVENUE.—For purposes of paragraph 
(1), the dollar amount of the annual base revenue for a fiscal 
year shall be—
H. R. 6833—51 
‘‘(A) for fiscal year 2023, $43,376,922; and 
‘‘(B) for fiscal years 2024 through 2027, the dollar 
amount of the total revenue amount established under 
paragraph (1) for the previous fiscal year, excluding any 
adjustments to such revenue amount under subsection 
(c)(4).’’. 
(c) ADJUSTMENTS; ANNUAL FEE SETTING.—Section 744H(c) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(c)) 
is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), by striking 
‘‘subsection 
(b)(2)(B)’’ 
and 
inserting 
‘‘subsection 
(b)(1)(B)’’; and 
(ii) in clause (i), by striking ‘‘subsection (b)’’ and 
inserting ‘‘subsection (b)(1)(A)’’; and 
(B) in subparagraph (B)(ii), by striking ‘‘Washington- 
Baltimore, DC–MD–VA–WV’’ and inserting ‘‘Washington- 
Arlington-Alexandria, DC–VA–MD–WV’’; 
(2) by striking paragraphs (2) through (4) and inserting 
the following: 
‘‘(2) STRATEGIC HIRING AND RETENTION ADJUSTMENT.—For 
each fiscal year, after the annual base revenue under subsection 
(b)(1)(A) is adjusted for inflation in accordance with paragraph 
(1), the Secretary shall further increase the fee revenue and 
fees by $150,000. 
‘‘(3) CAPACITY PLANNING ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For each fiscal year, the Secretary 
shall, in addition to the adjustments under paragraphs 
(1) and (2), further adjust the fee revenue and fees under 
this section for a fiscal year to reflect changes in the 
resource capacity needs of the Secretary for the process 
for the review of biosimilar biological product applications. 
‘‘(B) METHODOLOGY.—For purposes of this paragraph, 
the Secretary shall employ the capacity planning method-
ology utilized by the Secretary in setting fees for fiscal 
year 2021, as described in the notice titled ‘Biosimilar 
User Fee Rates for Fiscal Year 2021’ published in the 
Federal Register on August 4, 2020 (85 Fed. Reg. 47220). 
The workload categories used in applying such methodology 
in forecasting shall include only the activities described 
in that notice and, as feasible, additional activities that 
are directly related to the direct review of biosimilar 
biological product applications and supplements, including 
additional formal meeting types, the direct review of post-
marketing commitments and requirements, the direct 
review of risk evaluation and mitigation strategies, and 
the direct review of annual reports for approved biosimilar 
biological products. Subject to the exceptions in the pre-
ceding sentence, the Secretary shall not include as work-
load categories in applying such methodology in forecasting 
any non-core review activities, including those activities 
that the Secretary referenced for potential future use in 
such notice but did not utilize in setting fees for fiscal 
year 2021. 
‘‘(C) LIMITATIONS.—Under no circumstances shall an 
adjustment under this paragraph result in fee revenue
H. R. 6833—52 
for a fiscal year that is less than the sum of the amounts 
under subsections (b)(1)(A) (the annual base revenue for 
the fiscal year), (b)(1)(B) (the dollar amount of the inflation 
adjustment for the fiscal year), and (b)(1)(C) (the dollar 
amount of the strategic hiring and retention adjustment). 
‘‘(D) PUBLICATION
IN
FEDERAL
REGISTER.—The Sec-
retary shall publish in the Federal Register notice under 
paragraph (5) the fee revenue and fees resulting from the 
adjustment and the methodologies under this paragraph. 
‘‘(4) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) INCREASE.—For fiscal year 2023 and subsequent 
fiscal years, the Secretary shall, in addition to adjustments 
under paragraphs (1), (2), and (3), further increase the 
fee revenue and fees if such an adjustment is necessary 
to provide for at least 10 weeks of operating reserves of 
carryover user fees for the process for the review of bio-
similar biological product applications. 
‘‘(B) DECREASE.— 
‘‘(i) FISCAL YEAR 2023.—For fiscal year 2023, if the 
Secretary has carryover balances for such process in 
excess of 33 weeks of such operating reserves, the 
Secretary shall decrease such fee revenue and fees 
to provide for not more than 33 weeks of such operating 
reserves. 
‘‘(ii) FISCAL YEAR 2024.—For fiscal year 2024, if 
the Secretary has carryover balances for such process 
in excess of 27 weeks of such operating reserves, the 
Secretary shall decrease such fee revenue and fees 
to provide for not more than 27 weeks of such operating 
reserves. 
‘‘(iii) FISCAL
YEAR
2025
AND
SUBSEQUENT
FISCAL 
YEARS.—For fiscal year 2025 and subsequent fiscal 
years, if the Secretary has carryover balances for such 
process in excess of 21 weeks of such operating 
reserves, the Secretary shall decrease such fee revenue 
and fees to provide for not more than 21 weeks of 
such operating reserves. 
‘‘(C) FEDERAL
REGISTER
NOTICE.—If an adjustment 
under subparagraph (A) or (B) 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 paragraph (5)(B) establishing 
fee revenue and fees for the fiscal year involved.’’; and 
(3) in paragraph (5), in the matter preceding subparagraph 
(A), by striking ‘‘2018’’ and inserting ‘‘2023’’. 
(d) CREDITING AND AVAILABILITY OF FEES.—Subsection (f)(3) 
of section 744H of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–52(f)(3)) is amended by striking ‘‘2018 through 2022’’ 
and inserting ‘‘2023 through 2027’’. 
(e) WRITTEN REQUESTS FOR WAIVERS AND RETURNS; DISPUTES 
CONCERNING FEES.—Section 744H(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379j–52(h)) is amended to read as 
follows: 
‘‘(h) WRITTEN REQUESTS FOR WAIVERS AND RETURNS; DISPUTES 
CONCERNING FEES.—To qualify for consideration for a waiver under 
subsection (d), or for the return of any fee paid under this section, 
including if the fee is claimed to have been paid in error, a person