I 116th CONGRESS 2d Session H. R. 8633 IN THE HOUSE OF REPRESENTATIVES October 20, 2020 Mr. Hastings (for himself, Mr. Buchanan , Mr. Bishop of Georgia , and Ms. Sherrill ) 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.

1. Short title This Act may be cited as the Humane Research and Testing Act of 2020 . 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 ). 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: 6 National Center for Alternatives to Animals in Research and Testing 485E. Establishment; duties (a) Establishment Not later than one year after the date of enactment of the Humane Research and Testing Act of 2020 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. . 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.