II 
115TH CONGRESS 
2D SESSION 
H. R. 5554 
IN THE SENATE OF THE UNITED STATES 
JULY 17, 2018 
Received 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
reauthorize user fee programs relating to new animal 
drugs and generic new animal drugs. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Animal Drug and Ani-
mal Generic Drug User Fee Amendments of 2018’’. 
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT. 
(a) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents; references in Act. 
TITLE I—FEES RELATING TO ANIMAL DRUGS 
Sec. 101. Short title; finding. 
Sec. 102. Definitions. 
Sec. 103. Authority to assess and use animal drug fees. 
Sec. 104. Reauthorization; reporting requirements. 
Sec. 105. Savings clause. 
Sec. 106. Effective date. 
Sec. 107. Sunset dates. 
TITLE II—FEES RELATING TO GENERIC ANIMAL DRUGS 
Sec. 201. Short title; finding. 
Sec. 202. Authority to assess and use generic new animal drug fees. 
Sec. 203. Reauthorization; reporting requirements. 
Sec. 204. Savings clause. 
Sec. 205. Effective date. 
Sec. 206. Sunset dates. 
TITLE III—MISCELLANEOUS PROVISIONS 
Sec. 301. Electronic submissions. 
Sec. 302. Index of legally marketed unapproved new animal drugs for minor 
species. 
Sec. 303. Misbranded drugs and devices. 
Sec. 304. Conditional approval of new animal drugs. 
Sec. 305. Guidance addressing investigation designs. 
Sec. 306. Food additives intended for use in animal food. 
(b) REFERENCES IN ACT.—Except as otherwise spec-
ified, amendments made by this Act to a section or other 
provision of law are amendments to such section or other 
provision of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 301 et seq.). 
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TITLE I—FEES RELATING TO 
ANIMAL DRUGS 
SEC. 101. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Animal Drug User Fee Amendments of 2018’’. 
(b) FINDING.—Congress finds that the fees author-
ized by the amendments made in this title will be dedi-
cated toward expediting the animal drug development 
process and the review of new and supplemental animal 
drug applications and investigational animal drug submis-
sions as set forth in the goals identified for purposes of 
part 4 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act, in the letters from the Secretary 
of Health and Human Services to the Chairman of the 
Committee on Energy and Commerce of the House of 
Representatives and the Chairman of the Committee on 
Health, Education, Labor, and Pensions of the Senate as 
set forth in the Congressional Record. 
SEC. 102. DEFINITIONS. 
Section 739 (21 U.S.C. 379j–11) is amended— 
(1) by amending paragraph (1) to read as fol-
lows: 
‘‘(1)(A) The term ‘animal drug application’ 
means— 
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‘‘(i) an application for approval of any new 
animal drug submitted under section 512(b)(1); 
or 
‘‘(ii) an application for conditional ap-
proval of a new animal drug submitted under 
section 571. 
‘‘(B) Such term does not include either a new 
animal drug application submitted under section 
512(b)(2) or a supplemental animal drug applica-
tion.’’; and 
(2) in paragraph (8), by adding at the end the 
following: 
‘‘(I) The activities necessary for implemen-
tation of the United States and European 
Union Good Manufacturing Practice Mutual In-
spection Agreement with respect to animal drug 
products subject to review, including implemen-
tation activities prior to and following product 
approval.’’. 
SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 
FEES. 
(a) FEE REVENUE AMOUNTS.—Section 740(b) (21 
U.S.C. 379j–12(b)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)— 
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(C) by striking the flush text at the end; 
and 
(D) by adding at the end the following new 
subparagraph: 
‘‘(B) COMPOUNDED
BASIS.—The adjustment 
made each fiscal year after fiscal year 2020 under 
this paragraph shall be applied on a compounded 
basis to the revenue amount calculated under this 
paragraph for the most recent previous fiscal year.’’. 
(2) WORKLOAD ADJUSTMENTS.—Paragraph (3) 
of section 740(c) (21 U.S.C. 379j–12(c)) 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 
paragraph (2), the fee revenue amounts shall be 
further adjusted for such fiscal year to reflect 
changes in the workload of the Secretary for 
the process for the review of animal drug appli-
cations, subject to subparagraphs (B) and (C). 
With respect to such adjustment— 
‘‘(i) such adjustment shall be deter-
mined by the Secretary based on a weight-
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ed average of the change in the total num-
ber of animal drug applications, supple-
mental animal drug applications for which 
data with respect to safety or effectiveness 
are required, manufacturing supplemental 
animal drug applications, investigational 
animal drug study submissions, and inves-
tigational animal drug protocol submis-
sions submitted to the Secretary; and 
‘‘(ii) the Secretary shall publish in the 
Federal Register the fees resulting from 
such adjustment and the supporting meth-
odologies. 
‘‘(B) REDUCTION
OF
WORKLOAD-BASED 
INCREASE
BY
AMOUNT
OF
CERTAIN
EXCESS 
COLLECTIONS.—For each of fiscal years 2021 
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 
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year, up to the amount of such fee revenue in-
crease. 
‘‘(C) RULE OF APPLICATION.—Under no 
circumstances shall the 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.—Section 
740(c)(4) (21 U.S.C. 379j–12(c)(4)) is amended— 
(A) by striking ‘‘2018’’ each place it ap-
pears and inserting ‘‘2023’’; and 
(B) by striking ‘‘2019’’ and inserting 
‘‘2024’’. 
(c) EXEMPTIONS FROM FEES.—Section 740(d) (21 
U.S.C. 379j–12(d)) is amended— 
(1) in the subsection heading, by inserting ‘‘; 
EXEMPTIONS FROM FEES’’ after ‘‘REDUCTION’’; 
(2) by striking the heading of paragraph (1) 
and inserting ‘‘WAIVER OR REDUCTION’’; and 
(3) by adding at the end the following: 
‘‘(4) EXEMPTIONS FROM FEES.— 
‘‘(A) CERTAIN
LABELING
SUPPLEMENTS 
TO
ADD
NUMBER
OF
APPROVED
APPLICA-
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TION.—Fees under this section shall not apply 
with respect to any person who— 
‘‘(i) not later than September 30, 
2023, submits a supplemental animal drug 
application relating to a new animal drug 
application approved under section 512, 
solely to add the new animal drug applica-
tion number to the labeling of the drug in 
the manner specified in section 502(w)(3); 
and 
‘‘(ii) otherwise would be subject to 
fees under this section solely on the basis 
of such supplemental application. 
‘‘(B) CERTAIN
ANIMAL
DRUG
APPLICA-
TIONS.—Fees under paragraphs (2), (3), and 
(4) of subsection (a) shall not apply with re-
spect to any person who is the named applicant 
or sponsor of an animal drug application, sup-
plemental animal drug application, or investiga-
tional animal drug submission if such applica-
tion or submission involves the intentional 
genomic alteration of an animal that is in-
tended to produce a drug, device, or biological 
product subject to fees under section 736, 738, 
744B, or 744H.’’. 
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(d) CREDITING AND AVAILABILITY OF FEES.— 
(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
Section 740(g)(3) (21 U.S.C. 379j–12(g)(3)) is 
amended— 
(A) by striking ‘‘2014 through 2018’’ and 
inserting ‘‘2019 through 2023’’; 
(B) by striking ‘‘determined’’ and inserting 
‘‘established’’; and 
(C) by striking ‘‘paragraph (4)’’ and in-
serting ‘‘paragraph (5)’’. 
(2) EXCESS COLLECTIONS.—Section 740(g) (21 
U.S.C. 379j–12(g)) is amended by striking para-
graph (4) and inserting the following: 
‘‘(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). 
‘‘(5) 
RECOVERY
OF
COLLECTION
SHORT-
FALLS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B)— 
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‘‘(i) for fiscal year 2021, the amount 
of fees otherwise authorized to be collected 
under this section shall be increased by the 
amount, if any, by which the amount col-
lected under this section and appropriated 
for fiscal year 2019 falls below the amount 
of fees authorized for fiscal year 2019 
under paragraph (3); 
‘‘(ii) for fiscal year 2022, the amount 
of fees otherwise authorized to be collected 
under this section shall be increased by the 
amount, if any, by which the amount col-
lected under this section and appropriated 
for fiscal year 2020 falls below the amount 
of fees authorized for fiscal year 2020 
under paragraph (3); and 
‘‘(iii) for fiscal year 2023, the amount 
of fees otherwise authorized to be collected 
under this section shall be increased by the 
cumulative amount, if any, by which the 
amount collected under this section and 
appropriated for fiscal years 2021 and 
2022 (including estimated collections for 
fiscal year 2022) falls below the cumulative 
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amount of fees authorized for such fiscal 
years under paragraph (3). 
‘‘(B) REDUCTION
OF
SHORTFALL-BASED 
FEE INCREASE BY PRIOR YEAR EXCESS COL-
LECTIONS.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), the Secretary shall, in such manner as 
the Secretary determines appropriate, re-
duce any fee increase otherwise applicable 
for a fiscal year under subparagraph (A) 
by the amount of any excess collections 
under this section for preceding fiscal 
years (after fiscal year 2018). 
‘‘(ii) 
WORKLOAD-BASED
FEE
AC-
COUNTING.—In applying clause (i), the 
Secretary shall account for the reduction of 
workload-based fee revenue increases by 
excess 
collections 
under 
subsection 
(c)(3)(B), in such manner as needed to 
provide that no portion of any excess col-
lections described in clause (i) is applied 
for purposes of reducing fee increases 
under both such subsection (c)(3)(B) and 
this paragraph. 
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‘‘(C) RULE OF APPLICATION.—Under no 
circumstances shall adjustments under this 
paragraph result in fee revenues for a fiscal 
year that are less than the fee revenues for that 
fiscal year established in subsection (b), as ad-
justed or otherwise affected under subsection 
(c).’’. 
SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 740A (21 U.S.C. 379j–13) is amended— 
(1) in subsection (a), by striking ‘‘2013’’ and 
inserting ‘‘2018’’; 
(2) by striking ‘‘2014’’ each place it appears in 
subsections (a) and (b) and inserting ‘‘2019’’; and 
(3) in subsection (d), by striking ‘‘2018’’ each 
place it appears and inserting ‘‘2023’’. 
SEC. 105. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this title, 
part 4 of subchapter C of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–11 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 animal 
drug applications and supplemental animal drug applica-
tions (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 
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with respect to assessing and collecting any fee required 
by such part for a fiscal year prior to fiscal year 2019. 
SEC. 106. 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 4 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act, as amended by this title, shall be as-
sessed for animal drug applications and supplemental ani-
mal drug applications received on or after October 1, 
2018, regardless of the date of the enactment of this Act. 
SEC. 107. SUNSET DATES. 
(a) AUTHORIZATION.—Section 740 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12) shall 
cease to be effective October 1, 2023. 
(b) REPORTING REQUIREMENTS.—Section 740A of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–13) shall cease to be effective January 31, 2024. 
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
ber 1, 2018, subsections (a) and (b) of section 107 of the 
Animal Drug User Fee Amendments of 2013 (Public Law 
113–14) are repealed. 
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TITLE II—FEES RELATING TO 
GENERIC ANIMAL DRUGS 
SEC. 201. SHORT TITLE; FINDING. 
(a) SHORT TITLE.—This title may be cited as the 
‘‘Animal Generic Drug User Fee Amendments of 2018’’. 
(b) FINDING.—Congress finds that the fees author-
ized by the amendments made in this title will be dedi-
cated toward expediting the generic new animal drug de-
velopment process and the review of abbreviated applica-
tions for generic new animal drugs, supplemental abbre-
viated applications for generic new animal drugs, and in-
vestigational submissions for generic new animal drugs as 
set forth in the goals identified for purposes of part 5 of 
subchapter C of chapter VII of the Federal Food, Drug, 
and Cosmetic Act, in the letters from the Secretary of 
Health and Human Services to the Chairman of the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Chairman of the Committee on 
Health, Education, Labor and Pensions of the Senate as 
set forth in the Congressional Record. 
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 
ANIMAL DRUG FEES. 
(a) FEE REVENUE AMOUNTS.—Subsection (b) of sec-
tion 741 (21 U.S.C. 379j–21) is amended to read as fol-
lows: 
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‘‘(b) FEE REVENUE AMOUNTS.— 
‘‘(1) IN GENERAL.—Subject to subsections (c), 
(d), (f), and (g), for each of fiscal years 2019 
through 2023, the fees required under subsection (a) 
shall be established to generate a total revenue 
amount of $18,336,340. 
‘‘(2) TYPES
OF
FEES.—Of the total revenue 
amount established for a fiscal year under para-
graph (1)— 
‘‘(A) 25 percent shall be derived from fees 
under subsection (a)(1) (relating to abbreviated 
applications for a generic new animal drug); 
‘‘(B) 37.5 percent shall be derived from 
fees under subsection (a)(2) (relating to generic 
new animal drug products); and 
‘‘(C) 37.5 percent shall be derived from 
fees under subsection (a)(3) (relating to generic 
new animal drug sponsors).’’. 
(b) ANNUAL FEE SETTING; ADJUSTMENTS.— 
(1) INFLATION ADJUSTMENT.—Section 741(c) 
(21 U.S.C. 379j–21(c)) is amended— 
(A) 
by 
redesignating 
paragraphs 
(2) 
through (4) as paragraphs (3) through (5), re-
spectively; and 
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(B) by inserting after paragraph (1) the 
following: 
‘‘(2) INFLATION ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2020 
and subsequent fiscal years, the revenue 
amounts established under subsection (b) shall 
be adjusted by the Secretary by notice, pub-
lished in the Federal Register, for a fiscal year, 
by multiplying such revenue amounts by an 
amount equal to the sum of— 
‘‘(i) one; 
‘‘(ii) the average annual percent 
change in the cost, per full-time equivalent 
position of the Food and Drug Administra-
tion, of all personnel compensation and 
benefits paid with respect to such positions 
for the first 3 of the preceding 4 fiscal 
years for which data are available, multi-
plied by the average proportion of per-
sonnel compensation 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; and 
‘‘(iii) the average annual percent 
change that occurred in the Consumer 
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