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.’’. 
(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: 
‘‘(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 
(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 
(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.’’. 
(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
‘‘(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— 
(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-
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. 
2313. 
REAUTHORIZATION; 
REPORTING 
REQUIRE-
MENTS. 
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. 2314. SAVINGS CLAUSE. 
Notwithstanding the amendments made by this chap-
ter, 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 chapter, shall continue to be in effect with respect 
to abbreviated applications for a generic new animal drug 
and supplemental abbreviated applications for a generic
new animal 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 Administra-
tion for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal 
year 2024. 
SEC. 2315. EFFECTIVE DATE. 
The amendments made by this chapter shall take ef-
fect 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 
amended by this chapter, shall be assessed for abbreviated 
applications for a generic new animal drug and supple-
mental abbreviated applications for a generic new animal 
drug received on or after October 1, 2023, regardless of 
the date of enactment of this Act. 
SEC. 2316. 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. 
(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. 
Subtitle B—Public Health 
Extenders 
SEC. 2321. EXTENSION FOR COMMUNITY HEALTH CENTERS, 
NATIONAL HEALTH SERVICE CORPS, AND 
TEACHING HEALTH CENTERS THAT OPERATE 
GME PROGRAMS. 
(a) TEACHING HEALTH CENTERS THAT OPERATE 
GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 
340H(g) of the Public Health Service Act (42 U.S.C. 
256h(g)) is amended— 
(1) by striking ‘‘and $126,500,000’’ and insert-
ing ‘‘$126,500,000’’; and 
(2) by inserting ‘‘and $16,635,616 for the pe-
riod beginning on October 1, 2023, and ending on 
November 17, 2023,’’ before ‘‘to remain available’’. 
(b) EXTENSION
FOR COMMUNITY HEALTH CEN-
TERS.—Section 10503(b)(1)(F) of the Patient Protection 
and Affordable Care Act (42 U.S.C. 254b–2(b)(1)(F)) is 
amended— 
(1) by striking ‘‘and $4,000,000,000’’ and in-
serting ‘‘, $4,000,000,000’’; and
(2) by inserting ‘‘, and $526,027,397 for the 
period beginning on October 1, 2023, and ending on 
November 17, 2023’’ before the semicolon. 
(c) EXTENSION FOR THE NATIONAL HEALTH SERV-
ICE CORPS.—Section 10503(b)(2) of the Patient Protec-
tion and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) 
is amended— 
(1) in subparagraph (G), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (H), by striking the period 
at the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(I) $40,767,123 for the period beginning 
on October 1, 2023, and ending on November 
17, 2023.’’. 
(d) APPLICATION OF PROVISIONS.—Amounts appro-
priated pursuant to the amendments made by this section 
shall be subject to the requirements contained in Public 
Law 117–328 for funds for programs authorized under 
sections 330 through 340 of the Public Health Service Act 
(42 U.S.C. 254b et seq.). 
(e) TECHNICAL AND CONFORMING AMENDMENT.— 
Section 3014(h)(4) of title 18, United States Code, is 
amended—