I 117th CONGRESS 1st Session H. R. 4101 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.

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 . 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. 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 .