Title: Humane and Existing Alternatives in Research and Testing Sciences Act of 2021
Policy area: Health

Summary:
Humane and Existing Alternatives in Research and Testing Sciences Act of 2021 or the HEARTS Act of 2021
This bill expands the responsibilities of the National Institutes of Health (NIH) to promote research methods that do not use animals. Specifically, the NIH must (1) provide incentives for nonanimal research, and (2) require the evaluation of viable nonanimal alternatives before approving any research that involves animals.
Additionally, NIH applications for research grants involving animals must include an assurance that nonanimal methods for such research are not available.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4101 Introduced in House (IH)]

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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 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 2021'' or the ``HEARTS Act of 
2021''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The National Institutes of Health 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 million and 22 million 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 benefits for humans. 
        For example, according to NIH itself, ``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''.
            (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 surgery, 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 scientifically suitable non-animal methods 
        are available.
            (6) Under the system of oversight established by the Animal 
        Welfare Act (Public Law 89-544), researchers are supposed to 
        consider alternatives to animal use or painful procedures and 
        should not unnecessarily 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-effective, 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 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 non-animal methods in research proposals.
            ``(3) Ensure that, before any research involving the use of 
        animals is approved or performed all scientifically 
        satisfactory non-animal 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 non-animal 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 non-animal 
                methods described in the research proposals.
            ``(5) Establish and maintain research proposal guidelines 
        for conducting thorough searches for non-animal 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 non-animal method of 
                obtaining the result sought is not available; and''.
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