[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1291 Introduced in House (IH)]
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119th CONGRESS
1st Session
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
February 13, 2025
Mr. Calvert (for himself, Mr. Pappas, Ms. Malliotakis, Ms. Scholten,
Mr. Goldman of New York, and Mr. Davis of North Carolina) 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 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 Representatives 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 2025'' or the ``HEARTS Act of
2025''.
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
research in the United States is unknown. Such imprecise
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.
(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 becoming
available, and their number is growing. Cutting-edge
technologies have forged new frontiers in toxicology, biology,
and medicine that have produced human-relevant models,
including organoid cell cultures, 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 research.
(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 previous experiments. However,
oversight is lacking, and these provisions are not implemented
the way that Congress intended. As a result, researchers are
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 humane, cost-effective, and
scientifically suitable nonanimal 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 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 section 205 of the National
Institutes of Health Revitalization Act of 1993, calls for the
NIH to ``conduct or support research into. . . methods of
biomedical research and experimentation that do not require the
use of animals [and] methods of such research and
experimentation 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 suitable nonanimal methods based
on human biology will result in more progress toward
understanding human diseases and their treatments and cures. It
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 thwarted 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 subparagraph
(A), by striking ``paragraph'' and inserting
``subparagraph''; and
(ii) by redesignating subparagraphs (A) and
(B) as clauses (i) and (ii), respectively, 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 margins of such
subparagraphs (as so redesignated) two ems to the
right;
(C) in the matter preceding subparagraph (A) (as so
redesignated), by striking ``establish guidelines for
the following:'' and inserting the following: ``, with
respect to all research conducted or supported by the
National Institutes of Health, do the following:
``(1) Establish and maintain animal care guidelines for the
following:''; and
(D) by adding at the end the following:
``(2) Establish a system of meaningful incentives to
encourage the use of existing humane and scientifically
satisfactory nonanimal methods in research proposals.
``(3) Ensure that, before any research involving the use of
animals is approved or performed, all scientifically
satisfactory nonanimal methods for obtaining 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 expertise in
evaluating the adequacy of the searches for nonanimal
methods described in the research proposals.
``(5) Establish and maintain research proposal guidelines
for conducting thorough searches for nonanimal alternatives to
the use of animals for biomedical and behavioral research.'';
(2) in subsection (b)(1), by striking ``subsection (a)(3)''
and inserting ``subsection (a)(1)(C)''; and
(3) in subsection (c)(1)--
(A) in subparagraph (A)--
(i) by striking ``paragraphs (1) and (2)
of''; and
(ii) by striking ``and'' at the end; and
(B) by adding at the end the following:
``(C) a statement of assurance that a
scientifically satisfactory nonanimal method of
obtaining the result sought is not available; and''.
SEC. 4. NATIONAL CENTER FOR ALTERNATIVES TO ANIMALS IN RESEARCH AND
TESTING.
(a) Addition to List of Institutes and Centers.--Section 401(b) of
the Public Health Service Act (42 U.S.C. 281(b)) is amended--
(1) by redesignating paragraph (25) as paragraph (26); and
(2) by inserting after paragraph (24) the following new
paragraph:
``(25) The National Center for Alternatives to Animals in
Research and Testing.''.
(b) Conforming Change to Number of Institutes 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 and Existing Alternatives in Research and
Testing Sciences Act of 2025, 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 alternatives 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 the development 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
modeling, advanced imaging systems, artificial intelligence,
and other innovative methods;
``(2) train and inform scientists about the methods
developed pursuant to paragraph (1);
``(3) establish collaborations among research institutions
so that scientists who lack resources (such as bioengineering
and advanced bio-imaging equipment) can develop and use methods
developed pursuant 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:
(1) Not later than 2 years after the date of enactment 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 research 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 measure the progress
of the covered reporting entity in reducing the number
of animals used in federally 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 subparagraphs (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 submitting 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 training, experimentation, or biological
testing, or for related 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 testing;
and
(B) any Federal department or agency that uses
animals in research or testing.
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