II 
Calendar No. 210 
118TH CONGRESS 
1ST SESSION H. R. 1418 
IN THE SENATE OF THE UNITED STATES 
JULY 18, 2023 
Received 
SEPTEMBER 20, 2023 
Read twice and placed on the calendar 
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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Animal Drug and Ani-
mal Generic Drug User Fee Amendments of 2023’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents for this Act is the following: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—FEES RELATING TO ANIMAL DRUGS 
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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—SUPPORTING ANIMAL AND HUMAN HEALTH 
Sec. 301. Reporting requirements. 
Sec. 302. Definition of major species. 
Sec. 303. Antimicrobial resistance. 
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 2023’’. 
(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 (21 U.S.C. 379j–11 et seq.), in 
the letters from the Secretary of Health and Human Serv-
ices to the Chairman of the Committee on Energy and 
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Commerce of the House of Representatives and the Chair-
man of the Committee on Health, Education, Labor, and 
Pensions of the Senate as set forth in the Congressional 
Record. 
SEC. 102. DEFINITIONS. 
Section 739 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–11) is amended— 
(1) in paragraph (3), by striking ‘‘national drug 
code’’ and inserting ‘‘National Drug Code’’; and 
(2) by amending paragraph (8)(I) to read as 
follows: 
‘‘(I) The activities necessary for implemen-
tation of the United States and European 
Union Mutual Recognition Agreement for Phar-
maceutical Good Manufacturing Practice In-
spections, and the United States and United 
Kingdom Mutual Recognition Agreement Sec-
toral Annex for Pharmaceutical Good Manufac-
turing Practices, and other mutual recognition 
agreements, with respect to animal drug prod-
ucts subject to review, including implementation 
activities prior to and following product ap-
proval.’’. 
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SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG 
FEES. 
(a) IN GENERAL.—Section 740(a)(1)(A)(ii) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
12(a)(1)(A)(ii)) is amended— 
(1) in subclause (I), by striking ‘‘and’’ at the 
end; 
(2) in subclause (II), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(III) an application for condi-
tional approval under section 571 of a 
new animal drug for which an animal 
drug application submitted under sec-
tion 512(b)(1) has been previously ap-
proved under section 512(d)(1) for 
another intended use.’’. 
(b) FEE REVENUE AMOUNTS.—Section 740(b)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379j–12(b)(1)) is amended to read as follows: 
‘‘(1) IN GENERAL.—Subject to subsections (c), 
(d), (f), and (g), for each of fiscal years 2024 
through 2028, the fees required under subsection (a) 
shall be established to generate a total revenue 
amount of $33,500,000.’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.— 
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(1) ANNUAL FEE SETTING.—Section 740(c)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–12(c)(1)) is amended to read as follows: 
‘‘(1) ANNUAL FEE SETTING.—Not later than 
60 days before the start of each fiscal year begin-
ning after September 30, 2023, the Secretary 
shall— 
‘‘(A) establish for that fiscal year animal 
drug application fees, supplemental animal drug 
application fees, animal drug sponsor fees, ani-
mal drug establishment fees, and animal drug 
product fees based on the revenue amounts es-
tablished under subsection (b) and the adjust-
ments provided under this subsection; and 
‘‘(B) publish such fee revenue amounts 
and fees in the Federal Register.’’. 
(2) 
INFLATION
ADJUSTMENT.—Section 
740(c)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–12(c)(2)) is amended— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘2020’’ and inserting ‘‘2025’’; 
and 
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(ii) in clause (iii), by striking ‘‘Balti-
more’’ and inserting ‘‘Arlington-Alexan-
dria’’; and 
(B) in subparagraph (B), by striking 
‘‘2020’’ and inserting ‘‘2025’’. 
(3) 
WORKLOAD
ADJUSTMENTS.—Section 
740(c)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–12(c)(3)) is amended— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause 
(i)— 
(I) by striking ‘‘2020’’ and in-
serting ‘‘2025’’; and 
(II) by striking ‘‘subparagraphs 
(B) and (C)’’ and inserting ‘‘subpara-
graph (B)’’; 
(ii) in clause (i) by striking ‘‘and’’ at 
the end; and 
(iii) by striking clause (ii) and insert-
ing the following: 
‘‘(ii) such adjustment shall be made 
for each fiscal year that the adjustment de-
termined by the Secretary is greater than 
3 percent, except for the first fiscal year 
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that the adjustment is greater than 3 per-
cent; and 
‘‘(iii) the Secretary shall publish in 
the Federal Register notice under para-
graph (1) the amount of such adjustment 
and the supporting methodologies.’’; 
(B) by striking subparagraph (B); and 
(C) by redesignating subparagraph (C) as 
subparagraph (B). 
(4) 
FINAL
YEAR
ADJUSTMENT.—Section 
740(c)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–12(c)(4)) is amended to read 
as follows: 
‘‘(4) OPERATING RESERVE ADJUSTMENT.— 
‘‘(A) IN GENERAL.—For fiscal year 2025 
and each subsequent fiscal year, after the fee 
revenue amount established under subsection 
(b) is adjusted in accordance with paragraphs 
(2) and (3), the Secretary shall— 
‘‘(i) increase the fee revenue amount 
for such fiscal year, if necessary to provide 
an operating reserve of not less than 12 
weeks; or 
‘‘(ii) if the Secretary has an operating 
reserve in excess of the number of weeks 
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specified in subparagraph (C) for that fis-
cal year, the Secretary shall decrease the 
fee revenue amount to provide not more 
than the number of weeks specified in sub-
paragraph (C) for that fiscal year. 
‘‘(B) CARRYOVER USER FEES.—For pur-
poses of this paragraph, the operating reserve 
of carryover user fees for the process for the re-
view of animal drug applications does not in-
clude carryover user fees that have not been ap-
propriated. 
‘‘(C) NUMBER OF WEEKS OF OPERATING 
RESERVES.—The number of weeks of operating 
reserves specified in this subparagraph is— 
‘‘(i) 22 weeks for fiscal year 2025; 
‘‘(ii) 20 weeks for fiscal year 2026; 
‘‘(iii) 18 weeks for fiscal year 2027; 
and 
‘‘(iv) 16 weeks for fiscal year 2028. 
‘‘(D) PUBLICATION.—If an adjustment to 
the operating reserve is made under this para-
graph, the Secretary shall publish in the Fed-
eral Register notice under paragraph (1) the ra-
tionale for the amount of the adjustment and 
the supporting methodologies.’’. 
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SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 740A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–13) is amended— 
(1) in subsection (a), by striking ‘‘2018’’ and 
inserting ‘‘2023’’; 
(2) by striking ‘‘2019’’ each place it appears in 
subsections (a) and (b) and inserting ‘‘2024’’; and 
(3) in subsection (d)— 
(A) in paragraph (1), by striking ‘‘2023’’ 
and inserting ‘‘2028’’; and 
(B) in paragraph (5), by striking ‘‘2023’’ 
and inserting ‘‘2028’’. 
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, 2018, but before October 1, 2023, were 
accepted by the Food and Drug Administration for filing 
with respect to assessing and collecting any fee required 
by such part for a fiscal year prior to fiscal year 2024. 
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SEC. 106. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2023, 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 (21 U.S.C. 379j–11 et seq.), as amend-
ed by this title, shall be assessed for animal drug applica-
tions and supplemental animal drug applications received 
on or after October 1, 2023, regardless of the date of the 
enactment of this Act. 
SEC. 107. SUNSET DATES. 
(a) AUTHORIZATION.—Sections 739 and 740 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21 
U.S.C. 379j–11; 379j–12) shall cease to be effective Octo-
ber 1, 2028. 
(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, 2029. 
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
ber 1, 2023, subsections (a) and (b) of section 107 of the 
Animal Drug User Fee Amendments of 2018 (Public Law 
115–234) 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 2023’’. 
(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 (21 U.S.C. 379j–21 et seq.), in the let-
ters from the Secretary of Health and Human Services 
to the Chairman of the Committee on Energy and Com-
merce of the House of Representatives and the Chairman 
of the Committee on Health, Education, Labor and Pen-
sions of the Senate as set forth in the Congressional 
Record. 
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW 
ANIMAL DRUG FEES. 
(a) GENERIC INVESTIGATIONAL NEW ANIMAL DRUG 
FILE FEE.—Section 741(a) of the Federal Food, Drug, 
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and Cosmetic Act (21 U.S.C. 379j–21(a)) is amended by 
adding at the end the following: 
‘‘(4) GENERIC INVESTIGATIONAL NEW ANIMAL 
DRUG FILE FEE.— 
‘‘(A) IN GENERAL.— 
‘‘(i) NEW FILE REQUEST.—Each per-
son that submits a request to establish a 
generic investigational new animal drug 
file on or after October 1, 2023, shall be 
assessed a fee as established under sub-
section (c). 
‘‘(ii) NEW
SUBMISSION
TO
ESTAB-
LISHED FILE.—Each person that makes a 
submission to a generic investigational new 
animal drug file on or after October 1, 
2023, where such file was established prior 
to October 1, 2023, shall be assessed a fee 
for the first submission on or after October 
1, 2023, as established under subsection 
(c). 
‘‘(B) PAYMENT.— 
‘‘(i) NEW
FILE
REQUEST.—The fee 
required by subparagraph (A)(i) shall be 
due upon submission of the request to es-
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tablish the generic investigational new ani-
mal drug file. 
‘‘(ii) NEW
SUBMISSION
TO
ESTAB-
LISHED FILE.—The fee required by sub-
paragraph (A)(ii) shall be due upon the 
first submission to the generic investiga-
tional new animal drug file. 
‘‘(C) EXCEPTIONS.— 
‘‘(i) TERMINATING AN EXISTING GE-
NERIC
INVESTIGATIONAL
NEW
ANIMAL 
DRUG FILE.—If a person makes a submis-
sion to the generic investigational new ani-
mal drug file to terminate that file, the 
person shall not be subject to a fee under 
subparagraph (A)(ii) for that submission. 
‘‘(ii) TRANSFERRING AN EXISTING GE-
NERIC
INVESTIGATIONAL
NEW
ANIMAL 
DRUG FILE.—If a person makes a submis-
sion to the generic investigational new ani-
mal drug file to transfer that file to a dif-
ferent generic new animal drug sponsor, 
the person shall not be subject to a fee 
under subparagraph (A)(ii) for that sub-
mission.’’. 
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(b) FEE REVENUE AMOUNTS.—Section 741(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
21(b)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘2019 through 2023’’ and 
inserting ‘‘2024 through 2028’’; and 
(B) by striking ‘‘$18,336,340’’ and insert-
ing ‘‘$25,000,000’’; and 
(2) in paragraph (2)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘25 percent’’ and in-
serting ‘‘20 percent’’; and 
(ii) by inserting before the semicolon 
at the end the following: ‘‘and fees under 
subsection (a)(4) (relating to generic inves-
tigational new animal drug files)’’; 
(B) in subparagraph (B), by striking ‘‘37.5 
percent’’ and inserting ‘‘40 percent’’; and 
(C) in subparagraph (C), by striking ‘‘37.5 
percent’’ and inserting ‘‘40 percent’’. 
(c) ANNUAL FEE SETTING; ADJUSTMENTS.— 
(1) ANNUAL FEE SETTING.— Section 741(c)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–21(c)(1)) is amended to read as follows: 
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‘‘(1) ANNUAL
FEE
SETTING.—The Secretary 
shall establish, not later than 60 days before the 
start of each fiscal year beginning after September 
30, 2023, for that fiscal year— 
‘‘(A) abbreviated application fees that are 
based on the revenue amounts established 
under subsection (b), the adjustments provided 
under this subsection, and the amount of fees 
anticipated to be collected under subsection 
(a)(4) during that fiscal year; 
‘‘(B) generic new animal drug sponsor 
fees, and generic new animal drug product fees, 
based on the revenue amounts established 
under subsection (b) and the adjustments pro-
vided under this subsection; and 
‘‘(C) a generic investigational new animal 
drug file fee of $50,000 for each request or 
submission described in subsection (a)(4)(A).’’. 
(2) 
INFLATION
ADJUSTMENT.—Section 
741(c)(2) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–21(c)(2)) is amended— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘2020’’ and inserting ‘‘2025’’; 
and 
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(ii) in clause (iii), by striking ‘‘Balti-
more’’ and inserting ‘‘Arlington-Alexan-
dria’’; and 
(B) in subparagraph (B), by striking 
‘‘2020’’ and inserting ‘‘2025’’. 
(3) 
WORKLOAD
ADJUSTMENT.—Section 
741(c)(3) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–21(c)(3)) is amended— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘2020’’ and inserting ‘‘2025’’; 
(ii) in clause (i)— 
(I) by striking ‘‘and investiga-
tional generic new animal drug pro-
tocol submissions’’ and inserting ‘‘in-
vestigational generic new animal drug 
protocol submissions, requests to es-
tablish a generic investigational new 
animal drug file, and generic inves-
tigational new animal drug meeting 
requests’’; and 
(II) by striking ‘‘; and’’ and in-
serting a semicolon; 
(iii) by redesignating clause (ii) as 
clause (iii); and 
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(iv) by inserting after clause (i) the 
following: 
‘‘(ii) if the workload adjustment cal-
culated by the Secretary under clause (i) 
exceeds 25 percent, the Secretary shall use 
25 percent for the adjustment; and’’; and 
(B) in subparagraph (B), by striking 
‘‘2021 through 2023’’ and inserting ‘‘2026 
through 2028’’. 
(4) 
FINAL
YEAR
ADJUSTMENT.—Section 
741(c)(4) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–21(c)(4)) is amended— 
(A) by striking ‘‘2023’’ each place it ap-
pears and inserting ‘‘2028’’; and 
(B) by striking ‘‘2024’’ and inserting 
‘‘2029’’. 
(d) FEE WAIVER OR REDUCTION; EXEMPTION FROM 
FEES.—Subsection (d) of section 741 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) is 
amended to read as follows: 
‘‘(d) FEE WAIVER OR REDUCTION.—The Secretary 
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 animal drug is intended solely 
to provide for a minor use or minor species indication.’’. 
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(e) EFFECT OF FAILURE TO PAY FEES.—Section 
741(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379j–21(e)) is amended by striking ‘‘The Secretary 
may discontinue’’ and inserting ‘‘A request to establish a 
generic investigational new animal drug file that is sub-
mitted by a person subject to fees under subsection (a) 
shall be considered incomplete and shall not be accepted 
for action by the Secretary until all fees owed by such per-
son have been paid. The Secretary may discontinue’’. 
(f) ASSESSMENT OF FEES.—Section 741(f)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
21(f)(2)) is amended by striking ‘‘sponsors, and generic 
new animal drug products at any time’’ and inserting 
‘‘products, generic new animal drug sponsors, and generic 
investigational new animal drug files at any time’’. 
(g) CREDITING AND AVAILABILITY OF FEES.—Sec-
tion 741(g) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379j–21(g)) is amended— 
(1) in paragraph (3), by striking ‘‘2019 
through 2023’’ and inserting ‘‘2024 through 2028’’; 
(2) by striking the second paragraph (4) (relat-
ing to Offset), as added by section 202 of the Ani-
mal Generic Drug User Fee Amendments of 2013 
(Public Law 113–14); and 
(3) by adding at the end the following: 
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‘‘(5) 
RECOVERY
OF
COLLECTION
SHORT-
FALLS.—The amount of fees otherwise authorized to 
be collected under this section shall be increased— 
‘‘(A) for fiscal year 2026, by the amount, 
if any, by which the amount collected under this 
section and appropriated for fiscal year 2024 
falls below the amount of fees authorized for 
fiscal year 2024 under paragraph (3); 
‘‘(B) for fiscal year 2027, by the amount, 
if any, by which the amount collected under this 
section and appropriated for fiscal year 2025 
falls below the amount of fees authorized for 
fiscal year 2025 under paragraph (3); and 
‘‘(C) for fiscal year 2028, by the amount, 
if any, by which the amount collected under this 
section and appropriated for fiscal years 2026 
and 2027 (including estimated collections for 
fiscal year 2027) falls below the amount of fees 
authorized for such fiscal years under para-
graph (3).’’. 
(h) DEFINITIONS.—Section 741(k) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21(k)) is 
amended— 
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(1) by redesignating paragraphs (8), (9), (10), 
and (11) as paragraphs (9), (10), (11), and (13), re-
spectively; 
(2) by inserting after paragraph (7) the fol-
lowing: 
‘‘(8) GENERIC INVESTIGATIONAL NEW ANIMAL 
DRUG MEETING REQUEST.—The term ‘generic inves-
tigational new animal drug meeting request’ means 
a request submitted by a generic new animal drug 
sponsor to meet with the Secretary to discuss an in-
vestigational submission for a generic new animal 
drug.’’; 
(3) in paragraph (11) (as so redesignated), by 
adding at the end the following: 
‘‘(I) The activities necessary for explo-
ration and implementation of the United States 
and European Union Mutual Recognition 
Agreement for Pharmaceutical Good Manufac-
turing Practice Inspections, and the United 
States and United Kingdom Mutual Recogni-
tion Agreement Sectoral Annex for Pharma-
ceutical Good Manufacturing Practices, and 
other mutual recognition agreements, with re-
spect to generic new animal drug products sub-
ject to review, including implementation activi-
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ties prior to and following product approval.’’; 
and 
(4) by inserting after paragraph (11) (as so re-
designated) the following: 
‘‘(12) REQUEST TO ESTABLISH A GENERIC IN-
VESTIGATIONAL
NEW
ANIMAL
DRUG
FILE.—The 
term ‘request to establish a generic investigational 
new animal drug file’ means the submission to the 
Secretary of a request to establish a generic inves-
tigational new animal drug file to contain investiga-
tional submissions for a generic new animal drug.’’. 
SEC. 203. REAUTHORIZATION; REPORTING REQUIREMENTS. 
Section 742 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379j–22) is amended— 
(1) in subsection (a), by striking ‘‘2018’’ and 
inserting ‘‘2023’’; 
(2) by striking ‘‘2019’’ each place it appears in 
subsections (a) and (b) and inserting ‘‘2024’’; and 
(3) in subsection (d), by striking ‘‘2023’’ each 
place it appears and inserting ‘‘2028’’. 
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 
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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, 2018, but before October 1, 2023, 
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 
2024. 
SEC. 205. EFFECTIVE DATE. 
The amendments made by this title shall take effect 
on October 1, 2023, 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 (21 U.S.C. 379j–21 et seq.), as amend-
ed by this title, shall be assessed for abbreviated applica-
tions for a generic new animal drug and supplemental ab-
breviated applications for a generic new animal drug re-
ceived on or after October 1, 2023, regardless of the date 
of enactment of this Act. 
SEC. 206. SUNSET DATES. 
(a) AUTHORIZATION.—Section 741 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379j–21) shall 
cease to be effective October 1, 2028. 
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(b) REPORTING REQUIREMENTS.—Section 742 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j– 
22) shall cease to be effective January 31, 2029. 
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
ber 1, 2023, subsections (a) and (b) of section 206 of the 
Animal Generic Drug User Fee Amendments of 2018 
(Public Law 115–234) are repealed. 
TITLE III—SUPPORTING ANIMAL 
AND HUMAN HEALTH 
SEC. 301. REPORTING REQUIREMENTS. 
Section 740A of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379j–13), as amended by section 
104, is further amended— 
(1) in subsection (a)— 
(A) by striking ‘‘Beginning with’’ and in-
serting the following: 
‘‘(1) IN GENERAL.—Beginning with’’; and 
(B) by adding at the end the following: 
‘‘(2) CONTENTS.—The report under paragraph 
(1) shall include the following: 
‘‘(A) Data, analysis and discussion of the 
changes in the number of individuals hired and 
funded by fees collected pursuant to section 
740, and data, analysis, and discussion of the 
number of full-time equivalents in the animal 
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drug review program, including a breakdown by 
funding from fees collected pursuant to section 
740 versus budget authority, and by each divi-
sion within the Center for Veterinary Medicine, 
the Office of Regulatory Affairs, and the Office 
of the Commissioner. 
‘‘(B) Data, analysis, and discussion of the 
changes in the fee revenue amounts and costs 
for the process for the review of animal drug 
applications, including identifying— 
‘‘(i) the drivers of such changes; and 
‘‘(ii) changes in the total cost per full- 
time equivalent in the animal drug review 
program. 
‘‘(C) Data, analysis, and discussion of 
changes in the average full-time equivalent 
hours required to complete review of each type 
of animal drug application. 
‘‘(D) For fiscal years 2024 and 2025, of 
the meeting requests from animal drug spon-
sors for which the Secretary has determined 
that a face-to-face meeting is appropriate, the 
number of face-to-face meetings requested by 
sponsors to be conducted in person (in such 
manner as the Secretary shall prescribe on the 
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website of the Food and Drug Administration), 
and the number of such in-person meetings 
granted by the Secretary.’’; and 
(2) in subsection (d)— 
(A) in paragraph (5), by inserting a 
comma after ‘‘paragraph (4)’’; 
(B) by redesignating paragraph (6) as 
paragraph (7); 
(C) by inserting after paragraph (5) the 
following: 
‘‘(6) UPDATES TO CONGRESS.—The Secretary, 
in consultation with regulated industry, shall provide 
regular updates on negotiations on the reauthoriza-
tion of this part to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House 
of Representatives.’’; and 
(D) in paragraph (7) (as so redesig-
nated)— 
(i) in subparagraph (A)— 
(I) by striking ‘‘Before pre-
senting the recommendations devel-
oped under paragraphs (1) through 
(5) to Congress, the Secretary’’ and 
inserting ‘‘The Secretary’’; and 
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(II) by inserting before the pe-
riod at the end the following: ‘‘, not 
later than 30 days after each such ne-
gotiation meeting’’; and 
(ii) in subparagraph (B), by inserting 
‘‘, in sufficient detail,’’ after ‘‘shall sum-
marize’’. 
SEC. 302. DEFINITION OF MAJOR SPECIES. 
Section 201(nn) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(nn)) is amended by inserting 
‘‘, or remove species from,’’ after ‘‘add species to’’. 
SEC. 303. ANTIMICROBIAL RESISTANCE. 
(a) REPORT ON ANTIMICROBIAL STEWARDSHIP.— 
Not later than December 31, 2023, the Secretary of 
Health and Human Services, acting through the Commis-
sioner of Food and Drugs, shall submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report describing— 
(1) activities conducted by the Center for Vet-
erinary Medicine of the Food and Drug Administra-
tion (referred to in this section as ‘‘the Center’’) 
during the period of fiscal years 2019 through 2023 
to support antimicrobial stewardship in veterinary 
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settings, including ongoing activities and the tar-
geted completion date of such activities; and 
(2) with respect to antimicrobial stewardship in 
veterinary settings— 
(A) the goals of the Center regarding sup-
porting antimicrobial stewardship in veterinary 
settings; 
(B) activities the Center plans to execute 
during the period of fiscal years 2024 through 
2028 to support such goals, including targeted 
completion dates for such activities; and 
(C) metrics the Center plans to use to 
evaluate progress toward its goals regarding 
supporting antimicrobial stewardship in veteri-
nary settings. 
(b) ANNUAL PROGRESS REPORTS.—Not later than 
120 days after the end of each fiscal year during which 
fees are collected under section 740, the Secretary shall 
submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
that includes— 
(1) a description of activities conducted by the 
Center in the prior fiscal year to support anti-
microbial stewardship in veterinary settings, includ-
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ing progress made toward goals and activities speci-
fied in subsection (a)(2); 
(2) in the case of an incomplete activity de-
scribed in subsection (a)(2)(B) for which the target 
completion date has passed— 
(A) an explanation for why such target 
completion date was not met; and 
(B) if applicable, the updated expected 
completion date for such activity; 
(3) a description of emerging challenges related 
to antimicrobial stewardship in veterinary settings 
that impact Center activities; and 
(4) a description of activities undertaken to 
incentivize the development of new drugs for the 
treatment, prevention, or control of bacterial dis-
eases in animals. 
Passed the House of Representatives July 17, 2023. 
Attest: 
KEVIN F. MCCUMBER, 
Clerk. 
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Calendar No. 210 
118TH CONGRESS 
1ST SESSION 
H. R. 1418 
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. 
SEPTEMBER 20, 2023 
Read twice and placed on the calendar 
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