I 
117TH CONGRESS 
1ST SESSION H. R. 4101 
To amend the Public Health Service Act to ensure that non-animal methods 
are prioritized, where applicable and feasible, in proposals for all research 
to be conducted or supported by the National Institutes of Health, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 23, 2021 
Ms. ROYBAL-ALLARD (for herself and Mr. CALVERT) introduced 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 
non-animal methods are prioritized, where applicable and 
feasible, in proposals for all research to be conducted 
or supported by the National Institutes of Health, and 
for other purposes. 
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 ‘‘Humane and Existing 
Alternatives in Research and Testing Sciences Act of 
2021’’ or the ‘‘HEARTS Act of 2021’’. 
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SEC. 2. FINDINGS. 
Congress finds the following: 
(1) The National Institutes of Health has sup-
ported 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 million and 22 mil-
lion animals are used annually in the United States 
in research, education, and testing. 
(3) At the same time, however, a great deal of 
research that utilized animal studies yielded no ben-
efits for humans. For example, according to NIH 
itself, ‘‘approximately 30 percent of promising medi-
cations have failed in human clinical trials because 
they are found to be toxic despite promising pre-clin-
ical studies in animal models. About 60 percent of 
candidate drugs fail due to lack of efficacy’’. 
(4) The laboratory use of animals has also long 
been an issue of public concern because animals will, 
in most cases, experience fear, pain, disease or sur-
gery, and early death. 
(5) Much more has become known about the 
unsuitability of animal models for studying human 
disease and many more humane, cost-effective, and 
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scientifically suitable non-animal methods are avail-
able. 
(6) Under the system of oversight established 
by the Animal Welfare Act (Public Law 89–544), re-
searchers are supposed to consider alternatives to 
animal use or painful procedures and should not un-
necessarily duplicate previous experiments. However, 
oversight is generally weak and little heed is paid to 
the use of non-animal methods or the avoidance of 
duplication, thereby unnecessarily subjecting animals 
to pain, suffering, and death. 
(7) A system of active incentives is needed to 
encourage researchers to utilize humane, cost-effec-
tive, and scientifically suitable non-animal methods. 
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 
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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-
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 non-animal methods in re-
search proposals. 
‘‘(3) Ensure that, before any research involving 
the use of animals is approved or performed all sci-
entifically satisfactory non-animal methods for ob-
taining the results sought have been fully evaluated. 
‘‘(4) Ensure that— 
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‘‘(A) research proposals are reviewed by at 
least one person who has expertise in non-ani-
mal 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 non-animal methods described in the re-
search proposals. 
‘‘(5) Establish and maintain research proposal 
guidelines for conducting thorough searches for non- 
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 non-animal method of 
obtaining the result sought is not available; 
and’’. 
Æ 
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