I 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 pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Humane Research and 4 Testing Act of 2021’’. 5 SEC. 2. FINDINGS. 6 The Congress finds as follows: 7 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1744 IH (1) The mission of the National Institutes of 1 Health (NIH) is to seek fundamental knowledge 2 about the nature and behavior of living systems and 3 the application of that knowledge to enhance health, 4 lengthen life, and reduce illness and disability. 5 (2) Much of NIH’s research is carried out on 6 animals. However, the precise number of animals 7 used in research in the United States is unknown. 8 Estimates range between 17 million and 100 million 9 animals used annually. Such imprecise numbers 10 make it impossible to effectively track and reduce 11 the numbers of animals used, as mandated by the 12 NIH policies to ensure the smallest possible number 13 of animals are used. 14 (3) There is widespread agreement among sci- 15 entists and regulatory agencies that animal models 16 are poor predictors of the human response, with over 17 90 percent of new candidate drugs never making it 18 to market. 19 (4) More than 30 percent of promising medica- 20 tions have failed in human clinical trials because 21 they are found to be toxic despite promising pre-clin- 22 ical studies in animal models. An additional 65 per- 23 cent of candidate drugs that pass animal trials fail 24 due to lack of efficacy. 25 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1744 IH (5) Despite the ever-increasing growth in ani- 1 mal procedures, there is no corresponding increase 2 in the number of human medicines making it to the 3 clinic. 4 (6) Dramatically rising costs and extremely 5 high failure rates in drug development have led 6 many to re-evaluate the value of animal studies. 7 (7) Effective alternatives to animals are avail- 8 able and growing. Cutting-edge technology has 9 forged new frontiers in biology and medicine that 10 have produced human-relevant models, including 11 organoid cell cultures, organs-on-chips, genomics, in- 12 duced pluripotent adult stem cells, 3D modeling with 13 human cells, high throughput technology, molecular 14 imaging, computer models, in silico trials, digital im- 15 aging, artificial intelligence, and other innovative 16 methods—all of which have launched a technological 17 revolution in biomedical research. 18 (8) Despite these cutting-edge, human-relevant 19 methods, a preponderance of NIH research is car- 20 ried out on animals. A 2019 news release from NIH 21 indicates that 70 percent of NIH grant applications 22 relate to studies using mice. 23 (9) The American public has expressed concern 24 about subjecting animals to the pain of experimen- 25 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1744 IH tation. This concern grows as alternatives to re- 1 search on animals become available. 2 (10) Under the system of oversight established 3 by the National Institutes of Health Revitalization 4 Act of 1993 (Public Law 103–43), NIH is supposed 5 to outline a plan for reducing the use of animals in 6 research. Section 404C(a)(1) of the Public Health 7 Service Act (42 U.S.C. 283e(a)(1)), as added by sec- 8 tion 205 of the National Institutes of Health Revi- 9 talization Act of 1993, calls for NIH to ‘‘conduct or 10 support research into . . . methods of biomedical re- 11 search and experimentation that do not require the 12 use of animals and methods of such research and ex- 13 perimentation that reduce the number of animals 14 used in such research’’. 15 (11) A dedicated center that provides resources, 16 funding, and training to encourage researchers to 17 utilize humane, cost-effective, and scientifically suit- 18 able non-animal methods is needed to fulfill the in- 19 tent of the National Institutes of Health Revitaliza- 20 tion Act of 1993 (Public Law 103–43). 21 VerDate Sep 11 2014 04:39 May 07, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 1744 IH SEC. 3. NATIONAL CENTER FOR ALTERNATIVES TO ANI- 1 MALS IN RESEARCH AND TESTING. 2 (a) ADDITION TO LIST OF INSTITUTES AND CEN- 3 TERS.—Section 401 of the Public Health Service Act (42 4 U.S.C. 281) is amended— 5 (1) by redesignating paragraph (25) as para- 6 graph (26); and 7 (2) by inserting after paragraph (24) the fol- 8 lowing new paragraph: 9 ‘‘(25) National Center for Alternatives to Ani- 10 mals in Research and Testing.’’. 11 (b) CONFORMING CHANGE TO NUMBER OF INSTI- 12 TUTES AND CENTERS.—Section 401(d)(1) of the Public 13 Health Service Act (42 U.S.C. 281(d)(1)) is amended by 14 striking ‘‘27’’ and inserting ‘‘28’’. 15 (c) ESTABLISHMENT; DUTIES.—Part E of title IV of 16 the Public Health Service Act (42 U.S.C. 287 et seq.) is 17 amended by inserting after subpart 5 of such part E (42 18 U.S.C. 287c–21) the following new subpart: 19 ‘‘Subpart 6—National Center for Alternatives to 20 Animals in Research and Testing 21 ‘‘SEC. 485E. ESTABLISHMENT; DUTIES. 22 ‘‘(a) ESTABLISHMENT.—Not later than one year 23 after the date of enactment of the Humane Research and 24 Testing Act of 2021 the Secretary shall establish a Na- 25 tional Center for Alternatives to Animals in Research and 26 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 1744 IH Testing (in this subpart referred to as the ‘National Cen- 1 ter’) within the National Institutes of Health. 2 ‘‘(b) PURPOSES.—The sole purposes of the National 3 Center shall be— 4 ‘‘(1) developing, promoting, and funding alter- 5 natives to animal research and testing; and 6 ‘‘(2) developing a plan for reducing the number 7 of animals used in federally funded research and 8 testing. 9 ‘‘(c) DUTIES.—The Director of the National Center 10 shall— 11 ‘‘(1) provide assistance (including funding) to 12 federally funded researchers to incentivize research 13 and testing without the use of animals, based on ad- 14 vanced cell cultures or technology such as 3D 15 organoids, microphysiological systems, induced 16 pluripotent adult stem cell models, in silico mod- 17 eling, advanced imaging systems, artificial intel- 18 ligence, and other innovative methods; 19 ‘‘(2) train and inform scientists about these 20 available methods of research and testing without 21 the use of animals; 22 ‘‘(3) establish collaborations among research 23 scientists to assist those working in institutions 24 where research and testing scientists may lack re- 25 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 1744 IH sources (such as bioengineering and advanced bio- 1 imaging equipment) to carry out new and emerging 2 high-tech methods of research and testing without 3 the use of animals; and 4 ‘‘(4) tally and make publicly available informa- 5 tion on the numbers of animals used in federally 6 funded research and testing in order to implement 7 adequate steps to measure the reduction of animals 8 so used.’’. 9 SEC. 4. REPORTING BY FEDERALLY FUNDED RESEARCH 10 ENTITIES ON NUMBERS OF ANIMALS USED IN 11 RESEARCH AND TESTING. 12 (a) IN GENERAL.—Each covered reporting entity 13 shall do the following: 14 (1) Not later than 1 year after the date of en- 15 actment of this Act, report to the National Center 16 for Alternatives to Animals in Research and Testing 17 and make publicly available— 18 (A) the total number of animals used in 19 federally funded research and testing at any fa- 20 cilities of the covered reporting entity, 21 disaggregated by species; and 22 (B) the total number of such animals that 23 were bred or acquired for research or testing 24 purposes, disaggregated by species. 25 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 1744 IH (2) Every 2 years thereafter, update the latest 1 report of the entity under this section and make 2 publicly available such updated report to measure 3 the progress of the covered reporting entity in reduc- 4 ing the number of animals used in federally funded 5 research and testing. 6 (3) On an annual basis, develop and submit to 7 the National Center for Alternatives to Animals in 8 Research and Testing and make publicly available a 9 plan for reducing the numbers described in subpara- 10 graphs (A) and (B) of paragraph (1). 11 (b) STANDARDIZED PROCESS.—The Director of the 12 National Center for Alternatives to Animals in Research 13 and Testing shall establish a standardized process for sub- 14 mitting and updating reports and plans under subsection 15 (a), including for making such reports and plans publicly 16 available. 17 (c) DEFINITION.—In this section: 18 (1) The term ‘‘animal’’— 19 (A) means any vertebrate; and 20 (B) includes all warm-blooded and cold- 21 blooded species. 22 (2) The term ‘‘covered reporting entity’’ 23 means— 24 (A) any entity that— 25 VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 1744 IH (i) receives Federal funds for research 1 or testing; and 2 (ii) uses animals in research and test- 3 ing; and 4 (B) any Federal department or agency 5 that uses animals in research or testing. 6 Æ VerDate Sep 11 2014 19:34 May 03, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6301 E:\BILLS\H1744.IH H1744 pamtmann on DSKBC07HB2PROD with BILLS