I 
116TH CONGRESS 
2D SESSION 
H. R. 8633 
To amend the Public Health Service Act 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 
OCTOBER 20, 2020 
Mr. HASTINGS (for himself, Mr. BUCHANAN, Mr. BISHOP of Georgia, and Ms. 
SHERRILL) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act to provide for 
the establishment of the National Center for Alternatives 
to Animals in Research and Testing, and for other pur-
poses. 
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 Research and 
Testing Act of 2020’’. 
SEC. 2. FINDINGS. 
The Congress finds as follows: 
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(1) The mission of the National Institutes of 
Health (NIH) is to seek fundamental knowledge 
about the nature and behavior of living systems and 
the application of that knowledge to enhance health, 
lengthen life, and reduce illness and disability. 
(2) Much of NIH’s research is carried out on 
animals. However, the precise number of animals 
used in research in the United States is unknown. 
Estimates range between 17 million and 100 million 
animals used annually. Such imprecise numbers 
make it impossible to effectively track and reduce 
the numbers of animals used, as mandated by the 
NIH policies to ensure the smallest possible number 
of animals are used. 
(3) There is widespread agreement among sci-
entists and regulatory agencies that animal models 
are poor predictors of the human response, with over 
90 percent of new candidate drugs never making it 
to market. 
(4) More than 30 percent of promising medica-
tions have failed in human clinical trials because 
they are found to be toxic despite promising pre-clin-
ical studies in animal models. An additional 65 per-
cent of candidate drugs that pass animal trials fail 
due to lack of efficacy. 
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(5) Despite the ever-increasing growth in ani-
mal procedures, there is no corresponding increase 
in the number of human medicines making it to the 
clinic. 
(6) Dramatically rising costs and extremely 
high failure rates in drug development have led 
many to re-evaluate the value of animal studies. 
(7) Effective alternatives to animals are avail-
able and growing. Cutting-edge technology has 
forged new frontiers in biology and medicine that 
have produced human-relevant models, including 
organoid cell cultures, organs-on-chips, genomics, in-
duced pluripotent adult stem cells, 3D modeling with 
human cells, high throughput technology, molecular 
imaging, computer models, in silico trials, digital im-
aging, artificial intelligence, and other innovative 
methods—all of which have launched a technological 
revolution in biomedical research. 
(8) Despite these cutting-edge, human-relevant 
methods, a preponderance of NIH research is car-
ried out on animals. A 2019 news release from NIH 
indicates that 70 percent of NIH grant applications 
relate to studies using mice. 
(9) The American public has expressed concern 
about subjecting animals to the pain of experimen-
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tation. This concern grows as alternatives to re-
search on animals become available. 
(10) Under the system of oversight established 
by the National Institutes of Health Revitalization 
Act of 1993 (Public Law 103–43), NIH is supposed 
to outline a plan for reducing 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 sec-
tion 205 of the National Institutes of Health Revi-
talization Act of 1993, calls for NIH to ‘‘conduct or 
support research into . . . methods of biomedical re-
search and experimentation that do not require the 
use of animals and methods of such research and ex-
perimentation that reduce the number of animals 
used in such research’’. 
(11) A dedicated center that provides resources, 
funding, and training to encourage researchers to 
utilize humane, cost-effective, and scientifically suit-
able non-animal methods is needed to fulfill the in-
tent of the National Institutes of Health Revitaliza-
tion Act of 1993 (Public Law 103–43). 
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SEC. 3. 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) National Center for Alternatives to Ani-
mals 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’’. 
(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 Research and 
Testing Act of 2020 the Secretary shall establish a Na-
tional Center for Alternatives to Animals in Research and 
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Testing (in this subpart referred to as the ‘National Cen-
ter’) within the National Institutes of Health. 
‘‘(b) PURPOSES.—The sole purposes 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— 
‘‘(1) provide assistance (including funding) to 
federally funded researchers to incentivize research 
and testing without the use of animals, based on ad-
vanced 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 these 
available methods of research and testing without 
the use of animals; 
‘‘(3) establish collaborations among research 
scientists to assist those working in institutions 
where research and testing scientists may lack re-
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sources (such as bioengineering and advanced bio- 
imaging equipment) to carry out new and emerging 
high-tech methods of research and testing without 
the use of animals; and 
‘‘(4) tally and make publicly available informa-
tion on the numbers of animals used in federally 
funded research and testing in order to implement 
adequate steps to measure the reduction of animals 
so used.’’. 
SEC. 4. 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: 
(1) Not later than 1 year 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 total number of animals used in 
federally funded research and testing at any fa-
cilities 
of 
the 
covered 
reporting 
entity, 
disaggregated by species; and 
(B) the total number of such animals that 
were bred or acquired for research or testing 
purposes, disaggregated by species. 
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(2) Every 2 years thereafter, update the latest 
report of the entity under this section and make 
publicly available such updated report to measure 
the progress of the covered reporting entity in reduc-
ing the number of animals used in federally funded 
research and testing. 
(3) On an annual basis, 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). 
(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) The term ‘‘animal’’— 
(A) means any vertebrate; and 
(B) includes all warm-blooded and cold- 
blooded species. 
(2) The term ‘‘covered reporting entity’’ 
means— 
(A) any entity that— 
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(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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