119-hr1291

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1291 Introduced in House

    (IH) ]

<DOC>

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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