I
119THCONGRESS
1
STSESSION H. R. 1291
To amend the Public Health Service Act to ensure that nonanimal methods
are prioritized, where applicable and feasible, in proposals for all research
to be conducted or supported by the National Institutes of Health,
to provide for the establishment of the National Center for Alternatives
to Animals in Research and Testing, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY13, 2025
Mr. C
ALVERT(for himself, Mr. PAPPAS, Ms. MALLIOTAKIS, Ms. SCHOLTEN,
Mr. G
OLDMANof New York, and Mr. DAVISof North Carolina) intro-
duced the following bill; which was referred to the Committee on Energy
and Commerce
A BILL
To amend the Public Health Service Act to ensure that
nonanimal methods are prioritized, where applicable and
feasible, in proposals for all research to be conducted
or supported by the National Institutes of Health, to
provide for the establishment of the National Center
for Alternatives to Animals in Research and Testing,
and for other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
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SECTION 1. SHORT TITLE. 1
This Act may be cited as the ‘‘Humane and Existing 2
Alternatives in Research and Testing Sciences Act of 3
2025’’ or the ‘‘HEARTS Act of 2025’’. 4
SEC. 2. FINDINGS. 5
Congress finds the following: 6
(1) The National Institutes of Health (NIH) 7
has supported life-saving research that has greatly 8
improved the health and well-being not only of 9
Americans but also of people around the world. 10
(2) Much of this research has relied on animals. 11
It is estimated that between 17,000,000 and 12
100,000,000 animals are used annually in the 13
United States in research, education, and testing. 14
However, the precise number of animals used in re-15
search in the United States is unknown. Such im-16
precise numbers make it impossible to effectively 17
track and reduce the numbers of animals used. 18
(3) According to the NIH, ‘‘approximately 30 19
percent of promising medications have failed in 20
human clinical trials because they are found to be 21
toxic despite promising pre-clinical studies in animal 22
models. About 60 percent of candidate drugs fail 23
due to lack of efficacy.’’. These statistics indicate 24
that new, human-focused biology is needed. 25
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(4) The laboratory use of animals has also long 1
been a matter of public concern because, among 2
other things, there is very little publicly available 3
data provided by the NIH about the number and 4
species of animals used in research. 5
(5) Effective alternatives to animals are becom-6
ing available, and their number is growing. Cutting- 7
edge technologies have forged new frontiers in toxi-8
cology, biology, and medicine that have produced 9
human-relevant models, including organoid cell cul-10
tures, multiphysiological systems, genomics, induced 11
pluripotent adult stem cells, 3D modeling with 12
human cells, molecular imaging, computer models, in 13
silico trials, digital imaging, artificial intelligence, 14
and other innovative methods, all of which have 15
launched a technological revolution in biomedical re-16
search. 17
(6) The Animal Welfare Act (Public Law 89– 18
544) requires researchers to consider alternatives to 19
animal use for painful procedures and stresses that 20
researchers should not unnecessarily duplicate pre-21
vious experiments. However, oversight is lacking, 22
and these provisions are not implemented the way 23
that Congress intended. As a result, researchers are 24
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not capitalizing on nonanimal models that might 1
more effectively recapitulate human biology. 2
(7) A system of active incentives is needed to 3
encourage researchers to develop and utilize hu-4
mane, cost-effective, and scientifically suitable non-5
animal methods based on human biology. 6
(8) Further, under the National Institutes of 7
Health Revitalization Act of 1993 (Public Law 103– 8
43), the NIH is supposed to outline a plan for re-9
ducing the use of animals in research. Section 10
404C(a)(1) of the Public Health Service Act (42 11
U.S.C. 283e(a)(1)), as added by section 205 of the 12
National Institutes of Health Revitalization Act of 13
1993, calls for the NIH to ‘‘conduct or support re-14
search into. . . methods of biomedical research and 15
experimentation that do not require the use of ani-16
mals [and] methods of such research and experimen-17
tation that reduce the number of animals used in 18
such research’’. 19
(9) A dedicated center that provides resources, 20
funding, and training to encourage researchers to 21
utilize humane, cost-effective, and scientifically suit-22
able nonanimal methods based on human biology will 23
result in more progress toward understanding 24
human diseases and their treatments and cures. It 25
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will complete the vision that Congress set out in the 1
National Institutes of Health Revitalization Act of 2
1993 (Public Law 103–43), which has been thwart-3
ed because of lack of oversight. 4
SEC. 3. ANIMALS IN RESEARCH. 5
Section 495 of the Public Health Service Act (42 6
U.S.C. 289d) is amended— 7
(1) in subsection (a)— 8
(A) in paragraph (2)— 9
(i) in the matter preceding subpara-10
graph (A), by striking ‘‘paragraph’’ and in-11
serting ‘‘subparagraph’’; and 12
(ii) by redesignating subparagraphs 13
(A) and (B) as clauses (i) and (ii), respec-14
tively, and moving the margins of such 15
clauses (as so redesignated) two ems to the 16
right; 17
(B) by redesignating paragraphs (1), (2) 18
(as so amended), and (3) as subparagraphs (A), 19
(B), and (C), respectively, and moving the mar-20
gins of such subparagraphs (as so redesignated) 21
two ems to the right; 22
(C) in the matter preceding subparagraph 23
(A) (as so redesignated), by striking ‘‘establish 24
guidelines for the following:’’ and inserting the 25
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following: ‘‘, with respect to all research con-1
ducted or supported by the National Institutes 2
of Health, do the following: 3
‘‘(1) Establish and maintain animal care guide-4
lines for the following:’’; and 5
(D) by adding at the end the following: 6
‘‘(2) Establish a system of meaningful incen-7
tives to encourage the use of existing humane and 8
scientifically satisfactory nonanimal methods in re-9
search proposals. 10
‘‘(3) Ensure that, before any research involving 11
the use of animals is approved or performed, all sci-12
entifically satisfactory nonanimal methods for ob-13
taining the results sought have been fully evaluated. 14
‘‘(4) Ensure that— 15
‘‘(A) research proposals are reviewed by at 16
least one person who has expertise in nonanimal 17
research methods; and 18
‘‘(B) reviewers of the research proposals 19
have access to a reference librarian with exper-20
tise in evaluating the adequacy of the searches 21
for nonanimal methods described in the re-22
search proposals. 23
‘‘(5) Establish and maintain research proposal 24
guidelines for conducting thorough searches for non-25
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animal alternatives to the use of animals for bio-1
medical and behavioral research.’’; 2
(2) in subsection (b)(1), by striking ‘‘subsection 3
(a)(3)’’ and inserting ‘‘subsection (a)(1)(C)’’; and 4
(3) in subsection (c)(1)— 5
(A) in subparagraph (A)— 6
(i) by striking ‘‘paragraphs (1) and 7
(2) of’’; and 8
(ii) by striking ‘‘and’’ at the end; and 9
(B) by adding at the end the following: 10
‘‘(C) a statement of assurance that a sci-11
entifically satisfactory nonanimal method of ob-12
taining the result sought is not available; and’’. 13
SEC. 4. NATIONAL CENTER FOR ALTERNATIVES TO ANI-14
MALS IN RESEARCH AND TESTING. 15
(a) A
DDITION TOLIST OFINSTITUTES AND CEN-16
TERS.—Section 401(b) of the Public Health Service Act 17
(42 U.S.C. 281(b)) is amended— 18
(1) by redesignating paragraph (25) as para-19
graph (26); and 20
(2) by inserting after paragraph (24) the fol-21
lowing new paragraph: 22
‘‘(25) The National Center for Alternatives to 23
Animals in Research and Testing.’’. 24
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(b) CONFORMINGCHANGE TONUMBER OFINSTI-1
TUTES ANDCENTERS.—Section 401(d)(1) of the Public 2
Health Service Act (42 U.S.C. 281(d)(1)) is amended by 3
striking ‘‘27’’ and inserting ‘‘28’’. 4
(c) E
STABLISHMENT; DUTIES.—Part E of title IV of 5
the Public Health Service Act (42 U.S.C. 287 et seq.) is 6
amended by inserting after subpart 5 of such part E (42 7
U.S.C. 287c–21) the following new subpart: 8
‘‘Subpart 6—National Center for Alternatives to 9
Animals in Research and Testing 10
‘‘SEC. 485E. ESTABLISHMENT; DUTIES. 11
‘‘(a) E
STABLISHMENT.—Not later than one year 12
after the date of enactment of the Humane and Existing 13
Alternatives in Research and Testing Sciences Act of 14
2025, the Secretary shall establish a National Center for 15
Alternatives to Animals in Research and Testing (in this 16
subpart referred to as the ‘National Center’) within the 17
National Institutes of Health. The Center shall be headed 18
by a director, who shall be appointed by the Secretary. 19
‘‘(b) P
URPOSE.—The general purpose of the National 20
Center shall be— 21
‘‘(1) developing, promoting, and funding alter-22
natives to animal research and testing; and 23
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‘‘(2) developing a plan for reducing the number 1
of animals used in federally funded research and 2
testing. 3
‘‘(c) D
UTIES.—The Director of the National Center 4
shall— 5
‘‘(1) provide assistance (including funding) to 6
federally funded researchers to incentivize the devel-7
opment and qualification of nonanimal methods, 8
such as advanced cell cultures or technology such as 9
3D organoids, microphysiological systems, induced 10
pluripotent adult stem cell models, in silico mod-11
eling, advanced imaging systems, artificial intel-12
ligence, and other innovative methods; 13
‘‘(2) train and inform scientists about the 14
methods developed pursuant to paragraph (1); 15
‘‘(3) establish collaborations among research in-16
stitutions so that scientists who lack resources (such 17
as bioengineering and advanced bio-imaging equip-18
ment) can develop and use methods developed pursu-19
ant to paragraph (1); and 20
‘‘(4) collect information regarding the numbers 21
of animals used in federally funded research and 22
testing, and make such information available to the 23
public in a timely manner.’’. 24
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SEC. 5. REPORTING BY FEDERALLY FUNDED RESEARCH 1
ENTITIES ON NUMBERS OF ANIMALS USED IN 2
RESEARCH AND TESTING. 3
(a) I
NGENERAL.—Each covered reporting entity 4
shall do the following: 5
(1) Not later than 2 years after the date of en-6
actment of this Act, report to the National Center 7
for Alternatives to Animals in Research and Testing 8
and make publicly available— 9
(A) the number of animals used by the 10
covered reporting entity in federally funded re-11
search and testing at facilities of the covered 12
reporting entity, disaggregated by species; and 13
(B) the total number of such animals that 14
were bred or acquired by the covered reporting 15
entity for research or testing purposes, 16
disaggregated by species. 17
(2) Every 2 years thereafter— 18
(A) update the latest report of the covered 19
reporting entity under this section and make 20
publicly available such updated report to meas-21
ure the progress of the covered reporting entity 22
in reducing the number of animals used in fed-23
erally funded research and testing; and 24
(B) develop and submit to the National 25
Center for Alternatives to Animals in Research 26
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and Testing and make publicly available a plan 1
for reducing the numbers described in subpara-2
graphs (A) and (B) of paragraph (1). 3
(b) S
TANDARDIZEDPROCESS.—The Director of the 4
National Center for Alternatives to Animals in Research 5
and Testing shall establish a standardized process for sub-6
mitting and updating reports and plans under subsection 7
(a), including for making such reports and plans publicly 8
available. 9
(c) D
EFINITION.—In this section: 10
(1) A
NIMAL.—The term ‘‘animal’’ means any 11
live, nonhuman vertebrate animal or cephalopod 12
used or intended for use in research, research train-13
ing, experimentation, or biological testing, or for re-14
lated purposes. 15
(2) C
OVERED REPORTING ENTITY .—The term 16
‘‘covered reporting entity’’ means— 17
(A) any entity that— 18
(i) receives Federal funds for research 19
or testing; and 20
(ii) uses animals in research and test-21
ing; and 22
(B) any Federal department or agency 23
that uses animals in research or testing. 24
Æ
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