,i #aafth ,,congress #ast ,session ,h4 ,r4 #abji ,,in ,,the ,,house ,,of ,,representatives ,february #ac1 #bjai,ms4 ,roybal-,allard 7for herself and ,mr4 ,calvert7 introduced the following bill2 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 prioritized1 where applicable and feasible1 in proposals for all research to be conducted or supported by the ,national ,institutes of ,health1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,humane and ,existing ,alternatives in ,research and ,testing ,sciences ,act of #bjai or the ,,hearts ,act of #bjai4 #b4 ,findings ,congress finds the following3 7#a7 ,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 world4 7#b7 ,much of this research has relied on animals4 ,it is estimated that between #ag million and #bb million animals are used annually in the ,united ,states in research1 education1 and testing4 7#c7 ,at the same time1 however1 a great deal of research that utilized animal studies yielded no benefits for humans4 ,for example1 according to ,,nih itself1 approximately #cj percent of promising medications have failed in human clinical trials because they are found to be toxic despite promising pre-clinical studies in animal models4 ,about #fj percent of candidate drugs fail due to lack of efficacy4 7#d7 ,the laboratory use of animals has also long been an issue of public concern because animals will1 in most cases1 experience fear1 pain1 disease or surgery1 and early death4 7#e7 ,much more has become known about the unsuitability of animal models for studying human disease and many more humane1 cost-effective1 and scientifically suitable non-animal methods are available4 7#f7 ,under the system of oversight established by the ,animal ,welfare ,act 7,public ,law #hi-edd71 researchers are supposed to consider alternatives to animal use or painful procedures and should not unnecessarily duplicate previous experiments4 ,however1 oversight is generally weak and little heed is paid to the use of non-animal methods or the avoidance of duplication1 thereby unnecessarily subjecting animals to pain1 suffering1 and death4 7#g7 ,a system of active incentives is needed to encourage researchers to utilize humane1 cost-effective1 and scientifically suitable non-animal methods4 #c4 ,animals in research ,section #die of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;d7 is amended to read as follows3 #die4 ,animals in research 7a7 ,in general ,the ,secretary1 acting through the ,director of ,,nih1 shall1 with respect to all research conducted or supported by the ,national ,institutes of ,health1 do the following3 7#a7 ,establish a system of meaningful incentives to encourage the use of existing humane and scientifically satisfactory non-animal methods in research proposals4 7#b7 ,ensure that1 before any research involving the use of animals is approved or performed-- 7,a7 all scientifically satisfactory non-animal methods for obtaining the results sought have been fully evaluated2 and 7,b7 a detailed explanation and an analysis of the harms and benefits of such use of animals have been completed4 7#c7 ,ensure that-- 7,a7 research proposals are reviewed by at least one person who has expertise in non-animal research methods2 and 7,b7 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 proposals4 7#d7 ,establish and maintain research proposal guidelines for the following3 7,a7 ,conducting thorough searches for non-animal alternatives to the use of animals for biomedical and behavioral research4 7,b7 ,carrying out analyses of the harms and benefits of the use of animals in proposed research to assess whether the harms that would be caused to animals in terms of suffering1 pain1 and distress are justified by the expected outcomes1 taking into account ethical considerations and the expected benefits to human beings1 animals1 or the environment4 7#e7 ,establish and maintain animal care guidelines for the following3 7,a7 ,the proper care of animals to be used in biomedical and behavioral research4 7,b7 ,the proper treatment of animals while being used in such research4 ,guidelines under this paragraph shall require-- 7i7 the appropriate use of tranquilizers1 analgesics1 anesthetics1 paralytics1 and euthanasia for animals in such research2 and 7ii7 appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research4 ,such guidelines shall not be construed to prescribe methods of research4 7,c7 ,the organization and operation of animal care committees in accordance with subsection 7b74 7b7 ,animal care committees 7#a7 ,in general ,the guidelines under subsection 7a77#e77;,c7 shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this ,act 7including the ,national ,institutes of ,health and the national research institutes7 to assure compliance with the guidelines established under subsection 7a77#e74 7#b7 ,appointment of members ,each animal care committee shall-- 7,a7 be appointed by the chief executive officer of the entity for which the committee is established2 7,b7 be composed of not fewer than three members2 and 7,c7 include at least one individual who has no association with such entity and at least one doctor of veterinary medicine4 7#c7 ,requirements ,each animal care committee of a research entity shall-- 7,a7 review the care and treatment of animals in all animal study areas and facilities of the research entity at least semiannually to evaluate compliance with applicable guidelines established under subsection 7a77#e7 for appropriate animal care and treatment2 7,b7 keep appropriate records of reviews conducted under subparagraph 7,a72 and 7,c7 for each review conducted under subparagraph 7,a71 file with the ,director of ,,nih at least annually-- 7i7 a certification that the review has been conducted2 and 7ii7 reports of any violations of the guidelines under subsection 7a77#e7 or assurances required under paragraph 7#a7 which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations4 7#d7 ,minority views ,reports filed under paragraph 7#c77;,c7 shall include any minority views filed by members of the committee4 7c7 ,applications and contracts 7#a7 ,contents ,the ,director of ,,nih shall require each applicant for a grant1 contract1 or cooperative agreement involving research on animals which is administered by the ,national ,institutes of ,health or any national research institute to include in its application or contract proposal-- 7,a7 assurances satisfactory to the ,director of ,,nih that-- 7i7 the applicant meets the requirements under paragraphs 7#b71 7#c71 7#d71 and 7#e7 of subsection 7a7 and has an animal care committee which meets the requirements of subsection 7b72 and 7ii7 scientists1 animal technicians1 and other personnel involved with animal care1 treatment1 and use by the applicant have available to them instruction or training in-- 7,i7 the humane practice of animal maintenance and experimentation2 and 7,,ii7 the concept1 availability1 and use of research or testing methods that replace the use of animals1 limit the use of animals1 or limit animal distress2 7,b7 a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract2 7,c7 a statement of assurance that a scientifically satisfactory non-animal method of obtaining the result sought is not available2 and 7,d7 an analysis of the harms and benefits of the use of animals in the proposed research assessing whether the harms that would be caused to animals in terms of suffering1 pain1 and distress is justified by the expected outcomes1 taking into account ethical considerations and the expected benefits to human beings1 animals1 or the environment4 7#b7 ,regulatory process ,notwithstanding subsection 7a77#b7 of section #eec of title #e1 ,united ,states ,code1 regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section4 7d7 ,suspension or revocation ,if the ,director of ,,nih determines that-- 7#a7 the conditions of animal care1 treatment1 or use in an entity which is receiving a grant1 contract1 or cooperative agreement involving research on animals under this title do not meet applicable guidelines established under subsection 7a77#e72 7#b7 the entity has been notified by the ,director of ,,nih of such determination and has been given a reasonable opportunity to take corrective action2 and 7#c7 no action has been taken by the entity to correct such conditions1 the ,director of ,,nih shall suspend or revoke such grant1 contract1 or cooperative agreement under such conditions as the ,director determines appropriate4 7e7 ,protection of certain information ,no guideline or regulation promulgated under subsection 7a77#e7 or 7c7 may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential4 4