HEARTS Act of 2022

Subjects: Health

Summary:  <p><b>Humane and Existing Alternatives in Research and Testing Sciences Act of 2022 [<i>sic</i>] or the HEARTS Act of 2022 [<i>sic</i>]</b></p> <p>This bill establishes a center within the National Institutes of Health (NIH) and requires other activities to promote alternatives to using animals in research and testing.</p> <p>The duties of the center include developing nonanimal research models (e.g., advanced cell cultures and advanced imaging systems) and training scientists about the methods.</p> <p>Additionally, if a federal department or agency or federally funded research entity uses animals for research and testing, it must develop and update plans for reducing such uses and periodically report on the number and types of animals that they use to the center. The center must establish a standard process for entities to submit and update their plans and reports and for making the plans and reports publicly available.</p> <p>The NIH must also provide incentives for the use of nonanimal research and generally ensure that nonanimal alternatives are considered when reviewing and approving research applications and proposals. Further, NIH applications for research grants must include an assurance that nonanimal methods for carrying out the research are unavailable.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1024 Introduced in House (IH)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                H. R. 1024

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 14, 2023

Mr. Pappas (for himself 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 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 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 
        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 ``shall 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.''; 
        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 
                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 of the 
Public Health Service Act (42 U.S.C. 281) 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 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 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.
                                 &lt;all&gt;
</pre></body></html>