What This Bill Does
This bill extends the fees that drug companies pay to the Food and Drug Administration (FDA) when they submit new animal drugs and generic animal drugs for approval. These fees, collected through 2028, help the FDA review and approve these medications faster. The bill also adds new requirements for reporting on how the agency uses these fees and addresses concerns about antibiotic resistance in animals.
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Who It Affects
- Companies that develop and sell animal drugs
- Companies that develop and sell generic animal drugs
- The Food and Drug Administration's Center for Veterinary Medicine
- Congress (which receives reports on how fees are spent)
- Veterinarians and animal owners (indirectly, through drug availability)
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Key Provisions
- The FDA will collect $33,500,000 per year in animal drug fees from 2024 through 2028 to speed up the review of new and updated animal drug applications. (Sec. 103)
- The FDA will collect $25,000,000 per year in generic animal drug fees from 2024 through 2028 to speed up review of generic versions of animal drugs, and will charge $50,000 for companies that establish new investigational drug files. (Sec. 202)
- The FDA must report annually to Congress about staffing changes, costs, and how many in-person meetings animal drug companies requested versus received, at least for 2024 and 2025. (Sec. 301)
- The FDA must submit a report by December 31, 2023, describing its activities to combat antibiotic resistance in veterinary medicine, and then submit annual progress reports on this work. (Sec. 303)
- Companies may request waivers or reductions of fees if their generic animal drug is for rare uses or rare animal species. (Sec. 202)
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What Changes
If this bill becomes law, companies will pay new fees to submit generic animal drug applications and establish investigational drug files. The FDA's fee collection program will continue through 2028 instead of ending sooner. The FDA must provide more detailed reporting to Congress about how it spends these fees and what progress it makes on combating antibiotic resistance in animals. Some applications accepted before October 1, 2023, will follow the old fee rules, while those submitted after that date will follow the new rules.
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Important Definitions
- **Generic new animal drug:** A copy of an approved animal drug, similar to how generic human medicines work.
- **Investigational new animal drug submission:** Information a company submits to the FDA before formally applying for approval of an animal drug.
- **Conditional approval:** A type of approval for new animal drugs that may be granted before all testing is complete.
- **Minor use or minor species indication:** A drug intended for uses or animal species that represent small markets.
- **Antimicrobial stewardship:** Practices to reduce unnecessary use of antibiotics in animals to prevent bacteria from becoming resistant to these drugs.
- **Mutual Recognition Agreement:** Agreements between the United States and other countries (like the European Union and United Kingdom) that allow each country to accept the other's drug manufacturing inspections.
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Effective Date
The changes take effect October 1, 2023, or when the bill is signed into law, whichever is later. However, the new fees apply to applications received on or after October 1, 2023, regardless of when the bill is signed. The fee programs end October 1, 2028, and reporting requirements end January 31, 2029.
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-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Animal Drug and Ani-
4
mal Generic Drug User Fee Amendments of 2023’’.
5
SEC. 2. TABLE OF CONTENTS.
6
The table of contents for this Act is the following:
7
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
1
ANIMAL DRUGS
2
SEC. 101. SHORT TITLE; FINDING.
3
(a) SHORT TITLE.—This title may be cited as the
4
‘‘Animal Drug User Fee Amendments of 2023’’.
5
(b) FINDING.—Congress finds that the fees author-
6
ized by the amendments made in this title will be dedi-
7
cated toward expediting the animal drug development
8
process and the review of new and supplemental animal
9
drug applications and investigational animal drug submis-
10
sions as set forth in the goals identified for purposes of
11
part 4 of subchapter C of chapter VII of the Federal Food,
12
Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), in
13
the letters from the Secretary of Health and Human Serv-
14
ices to the Chairman of the Committee on Energy and
15
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Commerce of the House of Representatives and the Chair-
1
man of the Committee on Health, Education, Labor, and
2
Pensions of the Senate as set forth in the Congressional
3
Record.
4
SEC. 102. DEFINITIONS.
5
Section 739 of the Federal Food, Drug, and Cosmetic
6
Act (21 U.S.C. 379j–11) is amended—
7
(1) in paragraph (3), by striking ‘‘national drug
8
code’’ and inserting ‘‘National Drug Code’’; and
9
(2) by amending paragraph (8)(I) to read as
10
follows:
11
‘‘(I) The activities necessary for implemen-
12
tation of the United States and European
13
Union Mutual Recognition Agreement for Phar-
14
maceutical Good Manufacturing Practice In-
15
spections, and the United States and United
16
Kingdom Mutual Recognition Agreement Sec-
17
toral Annex for Pharmaceutical Good Manufac-
18
turing Practices, and other mutual recognition
19
agreements, with respect to animal drug prod-
20
ucts subject to review, including implementation
21
activities prior to and following product ap-
22
proval.’’.
23
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SEC. 103. AUTHORITY TO ASSESS AND USE ANIMAL DRUG
1
FEES.
2
(a) IN GENERAL.—Section 740(a)(1)(A)(ii) of the
3
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–
4
12(a)(1)(A)(ii)) is amended—
5
(1) in subclause (I), by striking ‘‘and’’ at the
6
end;
7
(2) in subclause (II), by striking the period at
8
the end and inserting ‘‘; and’’; and
9
(3) by adding at the end the following:
10
‘‘(III) an application for condi-
11
tional approval under section 571 of a
12
new animal drug for which an animal
13
drug application submitted under sec-
14
tion 512(b)(1) has been previously ap-
15
proved under section 512(d)(1) for
16
another intended use.’’.
17
(b) FEE REVENUE AMOUNTS.—Section 740(b)(1) of
18
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
19
379j–12(b)(1)) is amended to read as follows:
20
‘‘(1) IN GENERAL.—Subject to subsections (c),
21
(d), (f), and (g), for each of fiscal years 2024
22
through 2028, the fees required under subsection (a)
23
shall be established to generate a total revenue
24
amount of $33,500,000.’’.
25
(c) ANNUAL FEE SETTING; ADJUSTMENTS.—
26
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(1) ANNUAL FEE SETTING.—Section 740(c)(1)
1
of the Federal Food, Drug, and Cosmetic Act (21
2
U.S.C. 379j–12(c)(1)) is amended to read as follows:
3
‘‘(1) ANNUAL FEE SETTING.—Not later than
4
60 days before the start of each fiscal year begin-
5
ning after September 30, 2023, the Secretary
6
shall—
7
‘‘(A) establish for that fiscal year animal
8
drug application fees, supplemental animal drug
9
application fees, animal drug sponsor fees, ani-
10
mal drug establishment fees, and animal drug
11
product fees based on the revenue amounts es-
12
tablished under subsection (b) and the adjust-
13
ments provided under this subsection; and
14
‘‘(B) publish such fee revenue amounts
15
and fees in the Federal Register.’’.
16
(2)
INFLATION
ADJUSTMENT.—Section
17
740(c)(2) of the Federal Food, Drug, and Cosmetic
18
Act (21 U.S.C. 379j–12(c)(2)) is amended—
19
(A) in subparagraph (A)—
20
(i) in the matter preceding clause (i),
21
by striking ‘‘2020’’ and inserting ‘‘2025’’;
22
and
23
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(ii) in clause (iii), by striking ‘‘Balti-
1
more’’ and inserting ‘‘Arlington-Alexan-
2
dria’’; and
3
(B) in subparagraph (B), by striking
4
‘‘2020’’ and inserting ‘‘2025’’.
5
(3)
WORKLOAD
ADJUSTMENTS.—Section
6
740(c)(3) of the Federal Food, Drug, and Cosmetic
7
Act (21 U.S.C. 379j–12(c)(3)) is amended—
8
(A) in subparagraph (A)—
9
(i) in the matter preceding clause
10
(i)—
11
(I) by striking ‘‘2020’’ and in-
12
serting ‘‘2025’’; and
13
(II) by striking ‘‘subparagraphs
14
(B) and (C)’’ and inserting ‘‘subpara-
15
graph (B)’’;
16
(ii) in clause (i) by striking ‘‘and’’ at
17
the end; and
18
(iii) by striking clause (ii) and insert-
19
ing the following:
20
‘‘(ii) such adjustment shall be made
21
for each fiscal year that the adjustment de-
22
termined by the Secretary is greater than
23
3 percent, except for the first fiscal year
24
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that the adjustment is greater than 3 per-
1
cent; and
2
‘‘(iii) the Secretary shall publish in
3
the Federal Register notice under para-
4
graph (1) the amount of such adjustment
5
and the supporting methodologies.’’;
6
(B) by striking subparagraph (B); and
7
(C) by redesignating subparagraph (C) as
8
subparagraph (B).
9
(4)
FINAL
YEAR
ADJUSTMENT.—Section
10
740(c)(4) of the Federal Food, Drug, and Cosmetic
11
Act (21 U.S.C. 379j–12(c)(4)) is amended to read
12
as follows:
13
‘‘(4) OPERATING RESERVE ADJUSTMENT.—
14
‘‘(A) IN GENERAL.—For fiscal year 2025
15
and each subsequent fiscal year, after the fee
16
revenue amount established under subsection
17
(b) is adjusted in accordance with paragraphs
18
(2) and (3), the Secretary shall—
19
‘‘(i) increase the fee revenue amount
20
for such fiscal year, if necessary to provide
21
an operating reserve of not less than 12
22
weeks; or
23
‘‘(ii) if the Secretary has an operating
24
reserve in excess of the number of weeks
25
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specified in subparagraph (C) for that fis-
1
cal year, the Secretary shall decrease the
2
fee revenue amount to provide not more
3
than the number of weeks specified in sub-
4
paragraph (C) for that fiscal year.
5
‘‘(B) CARRYOVER USER FEES.—For pur-
6
poses of this paragraph, the operating reserve
7
of carryover user fees for the process for the re-
8
view of animal drug applications does not in-
9
clude carryover user fees that have not been ap-
10
propriated.
11
‘‘(C) NUMBER OF WEEKS OF OPERATING
12
RESERVES.—The number of weeks of operating
13
reserves specified in this subparagraph is—
14
‘‘(i) 22 weeks for fiscal year 2025;
15
‘‘(ii) 20 weeks for fiscal year 2026;
16
‘‘(iii) 18 weeks for fiscal year 2027;
17
and
18
‘‘(iv) 16 weeks for fiscal year 2028.
19
‘‘(D) PUBLICATION.—If an adjustment to
20
the operating reserve is made under this para-
21
graph, the Secretary shall publish in the Fed-
22
eral Register notice under paragraph (1) the ra-
23
tionale for the amount of the adjustment and
24
the supporting methodologies.’’.
25
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(d) EXEMPTION FROM FEES.—Section 740(d)(4) of
1
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
2
379j–12(d)(4)) is amended to read as follows:
3
‘‘(4) EXEMPTION
FROM
FEES.—Fees under
4
paragraphs (2), (3), and (4) of subsection (a) shall
5
not apply with respect to any person who is the
6
named applicant or sponsor of an animal drug appli-
7
cation, supplemental animal drug application, or in-
8
vestigational animal drug submission if such applica-
9
tion or submission involves the intentional genomic
10
alteration of an animal that is intended to produce
11
a drug, device, or biological product subject to fees
12
under section 736, 738, 744B, or 744H.’’.
13
(e) CREDITING AND AVAILABILITY OF FEES.—
14
(1) AUTHORIZATION
OF
APPROPRIATIONS.—
15
Section 740(g)(3) of the Federal Food, Drug, and
16
Cosmetic Act (21 U.S.C. 379j–12(g)(3)) is amended
17
by striking ‘‘2019 through 2023’’ and inserting
18
‘‘2024 through 2028’’.
19
(2) COLLECTION SHORTFALLS.—Section 740(g)
20
of the Federal Food, Drug, and Cosmetic Act (21
21
U.S.C. 379j–12(g)) is amended—
22
(A) in paragraph (3), by striking ‘‘and
23
paragraph (5)’’; and
24
(B) by striking paragraph (5).
25
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SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.
1
Section 740A of the Federal Food, Drug, and Cos-
2
metic Act (21 U.S.C. 379j–13) is amended—
3
(1) in subsection (a), by striking ‘‘2018’’ and
4
inserting ‘‘2023’’;
5
(2) by striking ‘‘2019’’ each place it appears in
6
subsections (a) and (b) and inserting ‘‘2024’’; and
7
(3) in subsection (d)—
8
(A) in paragraph (1), by striking ‘‘2023’’
9
and inserting ‘‘2028’’; and
10
(B) in paragraph (5), by striking ‘‘2023’’
11
and inserting ‘‘2028’’.
12
SEC. 105. SAVINGS CLAUSE.
13
Notwithstanding the amendments made by this title,
14
part 4 of subchapter C of chapter VII of the Federal Food,
15
Drug, and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as
16
in effect on the day before the date of enactment of this
17
title, shall continue to be in effect with respect to animal
18
drug applications and supplemental animal drug applica-
19
tions (as defined in such part as of such day) that on or
20
after October 1, 2018, but before October 1, 2023, were
21
accepted by the Food and Drug Administration for filing
22
with respect to assessing and collecting any fee required
23
by such part for a fiscal year prior to fiscal year 2024.
24
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SEC. 106. EFFECTIVE DATE.
1
The amendments made by this title shall take effect
2
on October 1, 2023, or the date of the enactment of this
3
Act, whichever is later, except that fees under part 4 of
4
subchapter C of chapter VII of the Federal Food, Drug,
5
and Cosmetic Act (21 U.S.C. 379j–11 et seq.), as amend-
6
ed by this title, shall be assessed for animal drug applica-
7
tions and supplemental animal drug applications received
8
on or after October 1, 2023, regardless of the date of the
9
enactment of this Act.
10
SEC. 107. SUNSET DATES.
11
(a) AUTHORIZATION.—Sections 739 and 740 of the
12
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 21
13
U.S.C. 379j–11; 379j–12) shall cease to be effective Octo-
14
ber 1, 2028.
15
(b) REPORTING REQUIREMENTS.—Section 740A of
16
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
17
379j–13) shall cease to be effective January 31, 2029.
18
(c) PREVIOUS SUNSET PROVISION.—Effective Octo-
19
ber 1, 2023, subsections (a) and (b) of section 107 of the
20
Animal Drug User Fee Amendments of 2018 (Public Law
21
115–234) are repealed.
22
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TITLE II—FEES RELATING TO
1
GENERIC ANIMAL DRUGS
2
SEC. 201. SHORT TITLE; FINDING.
3
(a) SHORT TITLE.—This title may be cited as the
4
‘‘Animal Generic Drug User Fee Amendments of 2023’’.
5
(b) FINDING.—Congress finds that the fees author-
6
ized by the amendments made in this title will be dedi-
7
cated toward expediting the generic new animal drug de-
8
velopment process and the review of abbreviated applica-
9
tions for generic new animal drugs, supplemental abbre-
10
viated applications for generic new animal drugs, and in-
11
vestigational submissions for generic new animal drugs as
12
set forth in the goals identified for purposes of part 5 of
13
subchapter C of chapter VII of the Federal Food, Drug,
14
and Cosmetic Act (21 U.S.C. 379j–21 et seq.), in the let-
15
ters from the Secretary of Health and Human Services
16
to the Chairman of the Committee on Energy and Com-
17
merce of the House of Representatives and the Chairman
18
of the Committee on Health, Education, Labor and Pen-
19
sions of the Senate as set forth in the Congressional
20
Record.
21
SEC. 202. AUTHORITY TO ASSESS AND USE GENERIC NEW
22
ANIMAL DRUG FEES.
23
(a) GENERIC INVESTIGATIONAL NEW ANIMAL DRUG
24
FILE FEE.—Section 741(a) of the Federal Food, Drug,
25
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[Text truncated for display. Full text available on Congress.gov.]