,i #aahth ,,congress #ast ,session ,h4 ,r4 #ajbd ,,in ,,the ,,house ,,of ,,representatives ,february #ad1 #bjbc,mr4 ,pappas 7for himself 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 nonanimal methods are prioritized1 where applicable and feasible1 in proposals for all research to be conducted or supported by the ,national ,institutes of ,health1 to provide for the establishment of the ,national ,center for ,alternatives to ,animals in ,research and ,testing1 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 #bjbb or the ,,hearts ,act of #bjbb4 #b4 ,findings ,congress finds the following3 7#a7 ,the ,national ,institutes of ,health 7,,nih7 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 #ag1jjj1jjj and #ajj1jjj1jjj animals are used annually in the ,united ,states in research1 education1 and testing4 ,however1 the precise number of animals used in research in the ,united ,states is unknown4 ,such imprecise numbers make it impossible to effectively track and reduce the numbers of animals used4 7#c7 ,according to the ,,nih1 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 efficacy44 ,these statistics indicate that new1 human-focused biology is needed4 7#d7 ,the laboratory use of animals has also long been a matter of public concern because1 among other things1 there is very little publicly available data provided by the ,,nih about the number and species of animals used in research4 7#e7 ,effective alternatives to animals are becoming available1 and their number is growing4 ,cutting-edge technologies have forged new frontiers in toxicology1 biology1 and medicine that have produced human-relevant models1 including organoid cell cultures1 multiphysiological systems1 genomics1 induced pluripotent adult stem cells1 #c;,d modeling with human cells1 molecular imaging1 computer models1 in silico trials1 digital imaging1 artificial intelligence1 and other innovative methods1 all of which have launched a technological revolution in biomedical research4 7#f7 ,the ,animal ,welfare ,act 7,public ,law #hi-edd7 requires researchers to consider alternatives to animal use for painful procedures and stresses that researchers should not unnecessarily duplicate previous experiments4 ,however1 oversight is lacking1 and these provisions are not implemented the way that ,congress intended4 ,as a result1 researchers are not capitalizing on nonanimal models that might more effectively recapitulate human biology4 7#g7 ,a system of active incentives is needed to encourage researchers to develop and utilize humane1 cost-effective1 and scientifically suitable nonanimal methods based on human biology4 7#h7 ,further1 under the ,national ,institutes of ,health ,revitalization ,act of #aiic 7,public ,law #ajc-dc71 the ,,nih is supposed to outline a plan for reducing the use of animals in research4 ,section #djd;,c7a77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhc;e7a77#a771 as added by section #bje of the ,national ,institutes of ,health ,revitalization ,act of #aiic1 calls for the ,,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 research4 7#i7 ,a dedicated center that provides resources1 funding1 and training to encourage researchers to utilize humane1 cost-effective1 and scientifically suitable nonanimal methods based on human biology will result in more progress toward understanding human diseases and their treatments and cures4 ,it will complete the vision that ,congress set out in the ,national ,institutes of ,health ,revitalization ,act of #aiic 7,public ,law #ajc-dc71 which has been thwarted because of lack of oversight4 #c4 ,animals in research ,section #die of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhi;d7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#b7-- 7i7 in the matter preceding subparagraph 7,a71 by striking paragraph and inserting subparagraph2 and 7ii7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively1 and moving the margins of such clauses 7as so redesignated7 two ems to the right2 7,b7 by redesignating paragraphs 7#a71 7#b7 7as so amended71 and 7#c7 as subparagraphs 7,a71 7,b71 and 7,c71 respectively1 and moving the margins of such subparagraphs 7as so redesignated7 two ems to the right2 7,c7 in the matter preceding subparagraph 7,a7 7as so redesignated71 by striking shall establish guidelines for the following3 and inserting the following3 1 with respect to all research conducted or supported by the ,national ,institutes of ,health1 do the following3 7#a7 ,establish and maintain animal care guidelines for the following3 2 and 7,d7 by adding at the end the following3 7#b7 ,establish a system of meaningful incentives to encourage the use of existing humane and scientifically satisfactory nonanimal methods in research proposals4 7#c7 ,ensure that1 before any research involving the use of animals is approved or performed all scientifically satisfactory nonanimal methods for obtaining the results sought have been fully evaluated4 7#d7 ,ensure that-- 7,a7 research proposals are reviewed by at least one person who has expertise in nonanimal 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 nonanimal methods described in the research proposals4 7#e7 ,establish and maintain research proposal guidelines for conducting thorough searches for nonanimal alternatives to the use of animals for biomedical and behavioral research4 2 and 7#b7 in subsection 7c77#a7-- 7,a7 in subparagraph 7,a71 by striking and at the end2 and 7,b7 by adding at the end the following3 7,c7 a statement of assurance that a scientifically satisfactory nonanimal method of obtaining the result sought is not available2 and 4 #d4 ,national ,center for ,alternatives to ,animals in ,research and ,testing 7a7 ,addition to list of institutes and centers ,section #dja of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha7 is amended-- 7#a7 by redesignating paragraph 7#be7 as paragraph 7#bf72 and 7#b7 by inserting after paragraph 7#bd7 the following new paragraph3 7#be7 ,the ,national ,center for ,alternatives to ,animals in ,research and ,testing4 4 7b7 ,conforming change to number of institutes and centers ,section #dja7;d77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bha7;d77#a77 is amended by striking #bg and inserting #bh4 7c7 ,establishment2 duties ,part ,e of title ,,iv of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhg et seq47 is amended by inserting after subpart #e of such part ,e 7#db ,u4,s4,c4 #bhg;c-#ba7 the following new subpart3 #f ,national ,center for ,alternatives to ,animals in ,research and ,testing #dhe;,e4 ,establishment2 duties 7a7 ,establishment ,not later than one year after the date of enactment of the ,humane and ,existing ,alternatives in ,research and ,testing ,sciences ,act of #bjbb1 the ,secretary shall establish a ,national ,center for ,alternatives to ,animals in ,research and ,testing 7in this subpart referred to as the ,national ,center7 within the ,national ,institutes of ,health4 ,the ,center shall be headed by a director1 who shall be appointed by the ,secretary4 7b7 ,purpose ,the general purpose of the ,national ,center shall be-- 7#a7 developing1 promoting1 and funding alternatives to animal research and testing2 and 7#b7 developing a plan for reducing the number of animals used in federally funded research and testing4 7c7 ,duties ,the ,director of the ,national ,center shall-- 7#a7 provide assistance 7including funding7 to federally funded researchers to incentivize the development and qualification of nonanimal methods1 such as advanced cell cultures or technology such as #c;,d organoids1 microphysiological systems1 induced pluripotent adult stem cell models1 in silico modeling1 advanced imaging systems1 artificial intelligence1 and other innovative methods2 7#b7 train and inform scientists about the methods developed pursuant to paragraph 7#a72 7#c7 establish collaborations among research institutions so that scientists who lack resources 7such as bioengineering and advanced bio-imaging equipment7 can develop and use methods developed pursuant to paragraph 7#a72 and 7#d7 collect information regarding the numbers of animals used in federally funded research and testing1 and make such information available to the public in a timely manner4 4 #e4 ,reporting by federally funded research entities on numbers of animals used in research and testing 7a7 ,in general ,each covered reporting entity shall do the following3 7#a7 ,not later than #b years after the date of enactment of this ,act1 report to the ,national ,center for ,alternatives to ,animals in ,research and ,testing and make publicly available-- 7,a7 the number of animals used by the covered reporting entity in federally funded research and testing at facilities of the covered reporting entity1 disaggregated by species2 and 7,b7 the total number of such animals that were bred or acquired by the covered reporting entity for research or testing purposes1 disaggregated by species4 7#b7 ,every #b years thereafter-- 7,a7 update the latest report of the covered reporting 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 testing2 and 7,b7 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 7,a7 and 7,b7 of paragraph 7#a74 7b7 ,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 7a71 including for making such reports and plans publicly available4 7c7 ,definition ,in this section3 7#a7 ,animal ,the term animal means any live1 nonhuman vertebrate animal or cephalopod used or intended for use in research1 research training1 experimentation1 or biological testing1 or for related purposes4 7#b7 ,covered reporting entity ,the term covered reporting entity means-- 7,a7 any entity that-- 7i7 receives ,federal funds for research or testing2 and 7ii7 uses animals in research and testing2 and 7,b7 any ,federal department or agency that uses animals in research or testing4