I 

116TH CONGRESS 

2D SESSION H. R. 8633 

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 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Humane Research and 

5 Testing Act of 2020’’. 

6 SEC. 2. FINDINGS. 

7 The Congress finds as follows: 


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1 (1) The mission of the National Institutes of 

2 Health (NIH) is to seek fundamental knowledge 

3 about the nature and behavior of living systems and 

4 the application of that knowledge to enhance health, 

5 lengthen life, and reduce illness and disability. 

6 (2) Much of NIH’s research is carried out on 

7 animals. However, the precise number of animals 

8 used in research in the United States is unknown. 

9 Estimates range between 17 million and 100 million 

10 animals used annually. Such imprecise numbers 

11 make it impossible to effectively track and reduce 

12 the numbers of animals used, as mandated by the 

13 NIH policies to ensure the smallest possible number 

14 of animals are used. 

15 (3) There is widespread agreement among sci16 entists and regulatory agencies that animal models 

17 are poor predictors of the human response, with over 

18 90 percent of new candidate drugs never making it 

19 to market. 

20 (4) More than 30 percent of promising medica21 tions have failed in human clinical trials because 

22 they are found to be toxic despite promising pre-clin23 ical studies in animal models. An additional 65 per24 cent of candidate drugs that pass animal trials fail 

25 due to lack of efficacy. 


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1 (5) Despite the ever-increasing growth in ani2 mal procedures, there is no corresponding increase 

3 in the number of human medicines making it to the 

4 clinic. 

5 (6) Dramatically rising costs and extremely 

6 high failure rates in drug development have led 

7 many to re-evaluate the value of animal studies. 

8 (7) Effective alternatives to animals are avail9 able and growing. Cutting-edge technology has 

10 forged new frontiers in biology and medicine that 

11 have produced human-relevant models, including 

12 organoid cell cultures, organs-on-chips, genomics, in13 duced pluripotent adult stem cells, 3D modeling with 

14 human cells, high throughput technology, molecular 

15 imaging, computer models, in silico trials, digital im16 aging, artificial intelligence, and other innovative 

17 methods—all of which have launched a technological 

18 revolution in biomedical research. 

19 (8) Despite these cutting-edge, human-relevant 

20 methods, a preponderance of NIH research is car21 ried out on animals. A 2019 news release from NIH 

22 indicates that 70 percent of NIH grant applications 

23 relate to studies using mice. 

24 (9) The American public has expressed concern 

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1 tation. This concern grows as alternatives to re2 search on animals become available. 

3 (10) Under the system of oversight established 

4 by the National Institutes of Health Revitalization 

5 Act of 1993 (Public Law 103–43), NIH is supposed 

6 to outline a plan for reducing the use of animals in 

7 research. Section 404C(a)(1) of the Public Health 

8 Service Act (42 U.S.C. 283e(a)(1)), as added by sec9 tion 205 of the National Institutes of Health Revi10 talization Act of 1993, calls for NIH to ‘‘conduct or 

11 support research into . . . methods of biomedical re12 search and experimentation that do not require the 

13 use of animals and methods of such research and ex14 perimentation that reduce the number of animals 

15 used in such research’’. 

16 (11) A dedicated center that provides resources, 

17 funding, and training to encourage researchers to 

18 utilize humane, cost-effective, and scientifically suit19 able non-animal methods is needed to fulfill the in20 tent of the National Institutes of Health Revitaliza21 tion Act of 1993 (Public Law 103–43). 


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1 SEC. 3. NATIONAL CENTER FOR ALTERNATIVES TO ANI2 MALS IN RESEARCH AND TESTING. 

3 (a) ADDITION TO LIST OF INSTITUTES AND CEN4 TERS.—Section 401 of the Public Health Service Act (42 

5 U.S.C. 281) is amended— 

6 (1) by redesignating paragraph (25) as para7 graph (26); and 

8 (2) by inserting after paragraph (24) the fol9 lowing new paragraph: 

10 ‘‘(25) National Center for Alternatives to Ani11 mals in Research and Testing.’’. 

12 (b) CONFORMING CHANGE TO NUMBER OF INSTI13 TUTES AND CENTERS.—Section 401(d)(1) of the Public 

14 Health Service Act (42 U.S.C. 281(d)(1)) is amended by 

15 striking ‘‘27’’ and inserting ‘‘28’’. 

16 (c) ESTABLISHMENT; DUTIES.—Part E of title IV of 

17 the Public Health Service Act (42 U.S.C. 287 et seq.) is 

18 amended by inserting after subpart 5 of such part E (42 

19 U.S.C. 287c–21) the following new subpart: 

20 ‘‘Subpart 6—National Center for Alternatives to 

21 Animals in Research and Testing 

22 ‘‘SEC. 485E. ESTABLISHMENT; DUTIES. 

23 ‘‘(a) ESTABLISHMENT.—Not later than one year 

24 after the date of enactment of the Humane Research and 

25 Testing Act of 2020 the Secretary shall establish a Na26 tional Center for Alternatives to Animals in Research and 


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1 Testing (in this subpart referred to as the ‘National Cen2 ter’) within the National Institutes of Health. 

3 ‘‘(b) PURPOSES.—The sole purposes of the National 

4 Center shall be— 

5 ‘‘(1) developing, promoting, and funding alter6 natives to animal research and testing; and 

7 ‘‘(2) developing a plan for reducing the number 

8 of animals used in federally funded research and 

9 testing. 

10 ‘‘(c) DUTIES.—The Director of the National Center 

11 shall— 

12 ‘‘(1) provide assistance (including funding) to 

13 federally funded researchers to incentivize research 

14 and testing without the use of animals, based on ad15 vanced cell cultures or technology such as 3D 

16 organoids, microphysiological systems, induced 

17 pluripotent adult stem cell models, in silico mod18 eling, advanced imaging systems, artificial intel19 ligence, and other innovative methods; 

20 ‘‘(2) train and inform scientists about these 

21 available methods of research and testing without 

22 the use of animals; 

23 ‘‘(3) establish collaborations among research 

24 scientists to assist those working in institutions 

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1 sources (such as bioengineering and advanced bio2 imaging equipment) to carry out new and emerging 

3 high-tech methods of research and testing without 

4 the use of animals; and 

5 ‘‘(4) tally and make publicly available informa6 tion on the numbers of animals used in federally 

7 funded research and testing in order to implement 

8 adequate steps to measure the reduction of animals 

9 so used.’’. 

10 SEC. 4. REPORTING BY FEDERALLY FUNDED RESEARCH 

11 ENTITIES ON NUMBERS OF ANIMALS USED IN 

12 RESEARCH AND TESTING. 

13 (a) IN GENERAL.—Each covered reporting entity 

14 shall do the following: 

15 (1) Not later than 1 year after the date of en16 actment of this Act, report to the National Center 

17 for Alternatives to Animals in Research and Testing 

18 and make publicly available— 

19 (A) the total number of animals used in 

20 federally funded research and testing at any fa21 cilities of the covered reporting entity, 

22 disaggregated by species; and 

23 (B) the total number of such animals that 

24 were bred or acquired for research or testing 

25 purposes, disaggregated by species. 


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1 (2) Every 2 years thereafter, update the latest 

2 report of the entity under this section and make 

3 publicly available such updated report to measure 

4 the progress of the covered reporting entity in reduc5 ing the number of animals used in federally funded 

6 research and testing. 

7 (3) On an annual basis, develop and submit to 

8 the National Center for Alternatives to Animals in 

9 Research and Testing and make publicly available a 

10 plan for reducing the numbers described in subpara11 graphs (A) and (B) of paragraph (1). 

12 (b) STANDARDIZED PROCESS.—The Director of the 

13 National Center for Alternatives to Animals in Research 

14 and Testing shall establish a standardized process for sub15 mitting and updating reports and plans under subsection 

16 (a), including for making such reports and plans publicly 

17 available. 

18 (c) DEFINITION.—In this section: 

19 (1) The term ‘‘animal’’— 

20 (A) means any vertebrate; and 

21 (B) includes all warm-blooded and cold22 blooded species. 

23 (2) The term ‘‘covered reporting entity’’ 

24 means— 

25 (A) any entity that— 


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1 (i) receives Federal funds for research 

2 or testing; and 

3 (ii) uses animals in research and test4 ing; and 

5 (B) any Federal department or agency 

6 that uses animals in research or testing. 

Æ 


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