SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Humane and Existing 
Alternatives in Research and Testing Sciences Act of 
2022’’ or the ‘‘HEARTS Act of 2022’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) The National Institutes of Health (NIH) 
has supported life-saving research that has greatly 
improved the health and well-being not only of 
Americans but also of people around the world. 
(2) Much of this research has relied on animals. 
It is estimated that between 17,000,000 and 
100,000,000 animals are used annually in the 
United States in research, education, and testing. 
However, the precise number of animals used in re-
search in the United States is unknown. Such im-
precise numbers make it impossible to effectively 
track and reduce the numbers of animals used. 
(3) According to the NIH, ‘‘approximately 30 
percent of promising medications have failed in 
human clinical trials because they are found to be 
toxic despite promising pre-clinical studies in animal 
models. About 60 percent of candidate drugs fail 
due to lack of efficacy.’’. These statistics indicate 
that new, human-focused biology is needed. 
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(4) The laboratory use of animals has also long 
been a matter of public concern because, among 
other things, there is very little publicly available 
data provided by the NIH about the number and 
species of animals used in research. 
(5) Effective alternatives to animals are becom-
ing available, and their number is growing. Cutting- 
edge technologies have forged new frontiers in toxi-
cology, biology, and medicine that have produced 
human-relevant models, including organoid cell cul-
tures, multiphysiological systems, genomics, induced 
pluripotent adult stem cells, 3D modeling with 
human cells, molecular imaging, computer models, in 
silico trials, digital imaging, artificial intelligence, 
and other innovative methods, all of which have 
launched a technological revolution in biomedical re-
search. 
(6) The Animal Welfare Act (Public Law 89– 
544) requires researchers to consider alternatives to 
animal use for painful procedures and stresses that 
researchers should not unnecessarily duplicate pre-
vious experiments. However, oversight is lacking, 
and these provisions are not implemented the way 
that Congress intended. As a result, researchers are 
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not capitalizing on nonanimal models that might 
more effectively recapitulate human biology. 
(7) A system of active incentives is needed to 
encourage researchers to develop and utilize hu-
mane, cost-effective, and scientifically suitable non-
animal methods based on human biology. 
(8) Further, under the National Institutes of 
Health Revitalization Act of 1993 (Public Law 103– 
43), the NIH is supposed to outline a plan for re-
ducing the use of animals in research. Section 
404C(a)(1) of the Public Health Service Act (42 
U.S.C. 283e(a)(1)), as added by section 205 of the 
National Institutes of Health Revitalization Act of 
1993, calls for the NIH to ‘‘conduct or support re-
search into. . . methods of biomedical research and 
experimentation that do not require the use of ani-
mals [and] methods of such research and experimen-
tation that reduce the number of animals used in 
such research’’. 
(9) A dedicated center that provides resources, 
funding, and training to encourage researchers to 
utilize humane, cost-effective, and scientifically suit-
able nonanimal methods based on human biology will 
result in more progress toward understanding 
human diseases and their treatments and cures. It 
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will complete the vision that Congress set out in the 
National Institutes of Health Revitalization Act of 
1993 (Public Law 103–43), which has been thwart-
ed because of lack of oversight. 
SEC. 3. ANIMALS IN RESEARCH. 
Section 495 of the Public Health Service Act (42 
U.S.C. 289d) is amended— 
(1) in subsection (a)— 
(A) in paragraph (2)— 
(i) in the matter preceding subpara-
graph (A), by striking ‘‘paragraph’’ and in-
serting ‘‘subparagraph’’; and 
(ii) by redesignating subparagraphs 
(A) and (B) as clauses (i) and (ii), respec-
tively, and moving the margins of such 
clauses (as so redesignated) two ems to the 
right; 
(B) by redesignating paragraphs (1), (2) 
(as so amended), and (3) as subparagraphs (A), 
(B), and (C), respectively, and moving the mar-
gins of such subparagraphs (as so redesignated) 
two ems to the right; 
(C) in the matter preceding subparagraph 
(A) (as so redesignated), by striking ‘‘shall es-
tablish guidelines for the following:’’ and insert-
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ing the following: ‘‘, with respect to all research 
conducted or supported by the National Insti-
tutes of Health, do the following: 
‘‘(1) Establish and maintain animal care guide-
lines for the following:’’; and 
(D) by adding at the end the following: 
‘‘(2) Establish a system of meaningful incen-
tives to encourage the use of existing humane and 
scientifically satisfactory nonanimal methods in re-
search proposals. 
‘‘(3) Ensure that, before any research involving 
the use of animals is approved or performed all sci-
entifically satisfactory nonanimal methods for ob-
taining the results sought have been fully evaluated. 
‘‘(4) Ensure that— 
‘‘(A) research proposals are reviewed by at 
least one person who has expertise in nonanimal 
research methods; and 
‘‘(B) reviewers of the research proposals 
have access to a reference librarian with exper-
tise in evaluating the adequacy of the searches 
for nonanimal methods described in the re-
search proposals. 
‘‘(5) Establish and maintain research proposal 
guidelines for conducting thorough searches for non-
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animal alternatives to the use of animals for bio-
medical and behavioral research.’’; and 
(2) in subsection (c)(1)— 
(A) in subparagraph (A), by striking 
‘‘and’’ at the end; and 
(B) by adding at the end the following: 
‘‘(C) a statement of assurance that a sci-
entifically satisfactory nonanimal method of ob-
taining the result sought is not available; and’’. 
SEC. 4. NATIONAL CENTER FOR ALTERNATIVES TO ANI-
MALS IN RESEARCH AND TESTING. 
(a) ADDITION TO LIST OF INSTITUTES AND CEN-
TERS.—Section 401 of the Public Health Service Act (42 
U.S.C. 281) is amended— 
(1) by redesignating paragraph (25) as para-
graph (26); and 
(2) by inserting after paragraph (24) the fol-
lowing new paragraph: 
‘‘(25) The National Center for Alternatives to 
Animals in Research and Testing.’’. 
(b) CONFORMING CHANGE TO NUMBER OF INSTI-
TUTES AND CENTERS.—Section 401(d)(1) of the Public 
Health Service Act (42 U.S.C. 281(d)(1)) is amended by 
striking ‘‘27’’ and inserting ‘‘28’’. 
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(c) ESTABLISHMENT; DUTIES.—Part E of title IV of 
the Public Health Service Act (42 U.S.C. 287 et seq.) is 
amended by inserting after subpart 5 of such part E (42 
U.S.C. 287c–21) the following new subpart: 
‘‘Subpart 6—National Center for Alternatives to 
Animals in Research and Testing 
‘‘SEC. 485E. ESTABLISHMENT; DUTIES. 
‘‘(a) ESTABLISHMENT.—Not later than one year 
after the date of enactment of the Humane and Existing 
Alternatives in Research and Testing Sciences Act of 
2022, the Secretary shall establish a National Center for 
Alternatives to Animals in Research and Testing (in this 
subpart referred to as the ‘National Center’) within the 
National Institutes of Health. The Center shall be headed 
by a director, who shall be appointed by the Secretary. 
‘‘(b) PURPOSE.—The general purpose of the National 
Center shall be— 
‘‘(1) developing, promoting, and funding alter-
natives to animal research and testing; and 
‘‘(2) developing a plan for reducing the number 
of animals used in federally funded research and 
testing. 
‘‘(c) DUTIES.—The Director of the National Center 
shall— 
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‘‘(1) provide assistance (including funding) to 
federally funded researchers to incentivize the devel-
opment and qualification of nonanimal methods, 
such as advanced cell cultures or technology such as 
3D organoids, microphysiological systems, induced 
pluripotent adult stem cell models, in silico mod-
eling, advanced imaging systems, artificial intel-
ligence, and other innovative methods; 
‘‘(2) train and inform scientists about the 
methods developed pursuant to paragraph (1); 
‘‘(3) establish collaborations among research in-
stitutions so that scientists who lack resources (such 
as bioengineering and advanced bio-imaging equip-
ment) can develop and use methods developed pursu-
ant to paragraph (1); and 
‘‘(4) collect information regarding the numbers 
of animals used in federally funded research and 
testing, and make such information available to the 
public in a timely manner.’’. 
SEC. 5. REPORTING BY FEDERALLY FUNDED RESEARCH 
ENTITIES ON NUMBERS OF ANIMALS USED IN 
RESEARCH AND TESTING. 
(a) IN GENERAL.—Each covered reporting entity 
shall do the following: 
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(1) Not later than 2 years after the date of en-
actment of this Act, report to the National Center 
for Alternatives to Animals in Research and Testing 
and make publicly available— 
(A) the number of animals used by the 
covered reporting entity in federally funded re-
search and testing at facilities of the covered 
reporting entity, disaggregated by species; and 
(B) the total number of such animals that 
were bred or acquired by the covered reporting 
entity 
for 
research 
or 
testing 
purposes, 
disaggregated by species. 
(2) Every 2 years thereafter— 
(A) update the latest report of the covered 
reporting entity under this section and make 
publicly available such updated report to meas-
ure the progress of the covered reporting entity 
in reducing the number of animals used in fed-
erally funded research and testing; and 
(B) develop and submit to the National 
Center for Alternatives to Animals in Research 
and Testing and make publicly available a plan 
for reducing the numbers described in subpara-
graphs (A) and (B) of paragraph (1). 
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(b) STANDARDIZED PROCESS.—The Director of the 
National Center for Alternatives to Animals in Research 
and Testing shall establish a standardized process for sub-
mitting and updating reports and plans under subsection 
(a), including for making such reports and plans publicly 
available. 
(c) DEFINITION.—In this section: 
(1) ANIMAL.—The term ‘‘animal’’ means any 
live, nonhuman vertebrate animal or cephalopod 
used or intended for use in research, research train-
ing, experimentation, or biological testing, or for re-
lated purposes. 
(2) COVERED REPORTING ENTITY.—The term 
‘‘covered reporting entity’’ means— 
(A) any entity that— 
(i) receives Federal funds for research 
or testing; and 
(ii) uses animals in research and test-
ing; and 
(B) any Federal department or agency 
that uses animals in research or testing. 
Æ 
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