Title: Humane Research and Testing Act of 2021
Policy area: Health

Summary:
Humane Research and Testing Act of 2021
This bill establishes the National Center for Alternatives to Animal Research and Testing within the National Institutes of Health to promote alternatives to animal research and testing and to reduce the number of animals used in such research and testing.
In addition, federal departments or agencies and federally funded research entities that use animals for research and testing must develop plans to reduce the use of animals in their activities. They must also annually report the number of animals that they use to the center, and the center must make this information publicly available.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1744 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 1744

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

                             March 10, 2021

   Mr. Hastings (for himself, Mr. Buchanan, Mrs. Beatty, Ms. Roybal-
  Allard, and Ms. Brownley) introduced the following bill; which was 
            referred to the Committee 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 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 Research and Testing Act of 
2021''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (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 scientists 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 medications have 
        failed in human clinical trials because they are found to be 
        toxic despite promising pre-clinical studies in animal models. 
        An additional 65 percent of candidate drugs that pass animal 
        trials fail due to lack of efficacy.
            (5) Despite the ever-increasing growth in animal 
        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 available 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, 
        induced pluripotent adult stem cells, 3D modeling with human 
        cells, high throughput technology, 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.
            (8) Despite these cutting-edge, human-relevant methods, a 
        preponderance of NIH research is carried 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 experimentation. This concern 
        grows as alternatives to research 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 section 205 of the National Institutes of Health 
        Revitalization Act of 1993, calls for 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''.
            (11) A dedicated center that provides resources, funding, 
        and training to encourage researchers to utilize humane, cost-
        effective, and scientifically suitable non-animal methods is 
        needed to fulfill the intent of the National Institutes of 
        Health Revitalization Act of 1993 (Public Law 103-43).

SEC. 3. 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) 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 Research and Testing Act of 2021 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.
    ``(b) Purposes.--The sole purposes 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 research and testing without 
        the use of animals, based on 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 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 resources (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 information 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 enactment 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 facilities 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.
            (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 reducing 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 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) 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--
                            (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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