HR 5554 RDS
Price Index for urban consumers (Wash-
ington-Baltimore, DC–MD–VA–WV; not 
seasonally adjusted; all items less food and 
energy; annual index) for the first 3 of the 
preceding 4 years for which data are avail-
able multiplied by the average proportion 
of all costs other than personnel compensa-
tion and benefits costs to total Food and 
Drug Administration costs for the first 3 
of the preceding 4 fiscal years for which 
data are available. 
‘‘(B) COMPOUNDED
BASIS.—The adjust-
ment made each fiscal year after fiscal year 
2020 under this paragraph shall be applied on 
a compounded basis to the revenue amount cal-
culated under this paragraph for the most re-
cent previous fiscal year.’’. 
(2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 
of section 741(c) (21 U.S.C. 379j–21(c)), as redesig-
nated, is amended to read as follows: 
‘‘(3) WORKLOAD ADJUSTMENTS.— 
‘‘(A) IN GENERAL.—For fiscal year 2020 
and subsequent fiscal years, after the fee rev-
enue amounts established under subsection (b) 
are adjusted for inflation in accordance with 
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paragraph (2), the fee revenue amounts shall be 
further adjusted for each such fiscal year to re-
flect changes in the workload of the Secretary 
for the process for the review of abbreviated ap-
plications for generic new animal drugs, subject 
to subparagraphs (B) and (C). With respect to 
such adjustment— 
‘‘(i) this adjustment shall be deter-
mined by the Secretary based on a weight-
ed average of the change in the total num-
ber of abbreviated applications for generic 
new animal drugs, manufacturing supple-
mental abbreviated applications for generic 
new animal drugs, investigational generic 
new animal drug study submissions, and 
investigational generic new animal drug 
protocol submissions submitted to the Sec-
retary; and 
‘‘(ii) the Secretary shall publish in the 
Federal Register the fees resulting from 
this adjustment and the supporting meth-
odologies. 
‘‘(B) REDUCTION
OF
WORKLOAD-BASED 
INCREASE
BY
AMOUNT
OF
CERTAIN
EXCESS 
COLLECTIONS.—For each of fiscal years 2021 
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through 2023, if application of the workload ad-
justment under subparagraph (A) increases the 
fee revenue amounts otherwise established for 
the fiscal year under subsection (b), as adjusted 
for inflation under paragraph (2), such fee rev-
enue increase shall be reduced by the amount of 
any excess collections, as described in sub-
section (g)(4), for the second preceding fiscal 
year, up to the amount of such fee revenue in-
crease. 
‘‘(C) RULE OF APPLICATION.—Under no 
circumstances 
shall 
workload 
adjustments 
under this paragraph result in fee revenues for 
a fiscal year that are less than the fee revenues 
for that fiscal year established under subsection 
(b), as adjusted for inflation under paragraph 
(2).’’. 
(3) FINAL YEAR ADJUSTMENT.—Paragraph (4) 
of section 741(c) (21 U.S.C. 379j–21(c)), as redesig-
nated, is amended by— 
(A) striking ‘‘2018’’ each place it appears 
and inserting ‘‘2023’’; and 
(B) striking ‘‘2019’’ and inserting ‘‘2024’’. 
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(c) FEE WAIVER OR REDUCTION; EXEMPTION FROM 
FEES.—Subsection (d) of section 741 (21 U.S.C. 379j– 
21) is amended to read as follows: 
‘‘(d) FEE WAIVER
OR REDUCTION; EXEMPTION 
FROM FEES.— 
‘‘(1) FEE WAIVER OR REDUCTION.—The Sec-
retary shall grant a waiver from or a reduction of 
one or more fees assessed under subsection (a) 
where the Secretary finds that the generic new ani-
mal drug is intended solely to provide for a minor 
use or minor species indication. 
‘‘(2) EXEMPTION FROM FEES.—Fees under this 
section shall not apply with respect to any person 
who— 
‘‘(A) not later than September 30, 2023, 
submits a supplemental abbreviated application 
for a generic new animal drug approved under 
section 512, solely to add the application num-
ber to the labeling of the drug in the manner 
specified in section 502(w)(3); and 
‘‘(B) otherwise would be subject to fees 
under this section solely on the basis of such 
supplemental abbreviated application.’’. 
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(d) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 741(g) (21 U.S.C. 379j–21) is amended by striking 
paragraph (3) and inserting the following paragraphs: 
‘‘(3) AUTHORIZATION
OF
APPROPRIATIONS.— 
For each of the fiscal years 2019 through 2023, 
there is authorized to be appropriated for fees under 
this section an amount equal to the total revenue 
amount established under subsection (b) for the fis-
cal year, as adjusted or otherwise affected under 
subsection (c). 
‘‘(4) EXCESS COLLECTIONS.—If the sum total 
of fees collected under this section for a fiscal year 
exceeds the amount of fees authorized to be appro-
priated for such year under paragraph (3), the ex-
cess collections shall be credited to the appropria-
tions account of the Food and Drug Administration 
as provided in paragraph (1).’’. 
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 742 (21 U.S.C. 379j–22) is amended— 
(1) in subsection (a), by striking ‘‘2013’’ and 
inserting ‘‘2018’’; 
(2) in subsection (b), by striking ‘‘Committee 
on Health, Education, Labor, and Pensions’’ and in-
serting ‘‘the Committee on Health, Education, 
Labor and Pensions’’; 
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(3) by striking ‘‘2014’’ each place it appears in 
subsections (a) and (b) and inserting ‘‘2019’’; and 
(4) in subsection (d), by striking ‘‘2018’’ each 
place it appears and inserting ‘‘2023’’. 
SEC. 204. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 5 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–21 et seq.), as 
in effect on the day before the date of enactment of this 
title, shall continue to be in effect with respect to abbre-
viated applications for a generic new animal drug and sup-
plemental abbreviated applications for a generic new ani-
mal drug (as defined in such part as of such day) that 
on or after October 1, 2013, but before October 1, 2018, 
were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee re-
quired by such part for a fiscal year prior to fiscal year 
2019. 
SEC. 205. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2018, or the date of the enactment of this 
Act, whichever is later, except that fees under part 5 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act, as amended by this title, shall be as-
sessed for abbreviated applications for a generic new ani-
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