I 

118TH CONGRESS 

1ST SESSION H. R. 1024 

To amend the Public Health Service Act to ensure that nonanimal methods 

are prioritized, where applicable and feasible, in proposals for all research 

to be conducted or supported by the National Institutes of Health, 

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 

FEBRUARY 14, 2023 

Mr. PAPPAS (for himself 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 

nonanimal methods are prioritized, where applicable and 

feasible, in proposals for all research to be conducted 

or supported by the National Institutes of Health, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Humane and Existing 

3 Alternatives in Research and Testing Sciences Act of 

4 2022’’ or the ‘‘HEARTS Act of 2022’’. 

5 SEC. 2. FINDINGS. 

6 Congress finds the following: 

7 (1) The National Institutes of Health (NIH) 

8 has supported life-saving research that has greatly 

9 improved the health and well-being not only of 

10 Americans but also of people around the world. 

11 (2) Much of this research has relied on animals. 

12 It is estimated that between 17,000,000 and 

13 100,000,000 animals are used annually in the 

14 United States in research, education, and testing. 

15 However, the precise number of animals used in re16 search in the United States is unknown. Such im17 precise numbers make it impossible to effectively 

18 track and reduce the numbers of animals used. 

19 (3) According to the NIH, ‘‘approximately 30 

20 percent of promising medications have failed in 

21 human clinical trials because they are found to be 

22 toxic despite promising pre-clinical studies in animal 

23 models. About 60 percent of candidate drugs fail 

24 due to lack of efficacy.’’. These statistics indicate 

25 that new, human-focused biology is needed. 


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1 (4) The laboratory use of animals has also long 

2 been a matter of public concern because, among 

3 other things, there is very little publicly available 

4 data provided by the NIH about the number and 

5 species of animals used in research. 

6 (5) Effective alternatives to animals are becom7 ing available, and their number is growing. Cutting8 edge technologies have forged new frontiers in toxi9 cology, biology, and medicine that have produced 

10 human-relevant models, including organoid cell cul11 tures, multiphysiological systems, genomics, induced 

12 pluripotent adult stem cells, 3D modeling with 

13 human cells, molecular imaging, computer models, in 

14 silico trials, digital imaging, artificial intelligence, 

15 and other innovative methods, all of which have 

16 launched a technological revolution in biomedical re17 search. 

18 (6) The Animal Welfare Act (Public Law 89– 

19 544) requires researchers to consider alternatives to 

20 animal use for painful procedures and stresses that 

21 researchers should not unnecessarily duplicate pre22 vious experiments. However, oversight is lacking, 

23 and these provisions are not implemented the way 

24 that Congress intended. As a result, researchers are 


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1 not capitalizing on nonanimal models that might 

2 more effectively recapitulate human biology. 

3 (7) A system of active incentives is needed to 

4 encourage researchers to develop and utilize hu5 mane, cost-effective, and scientifically suitable non6 animal methods based on human biology. 

7 (8) Further, under the National Institutes of 

8 Health Revitalization Act of 1993 (Public Law 103– 

9 43), the NIH is supposed to outline a plan for re10 ducing the use of animals in research. Section 

11 404C(a)(1) of the Public Health Service Act (42 

12 U.S.C. 283e(a)(1)), as added by section 205 of the 

13 National Institutes of Health Revitalization Act of 

14 1993, calls for the NIH to ‘‘conduct or support re15 search into. . . methods of biomedical research and 

16 experimentation that do not require the use of ani17 mals [and] methods of such research and experimen18 tation that reduce the number of animals used in 

19 such research’’. 

20 (9) A dedicated center that provides resources, 

21 funding, and training to encourage researchers to 

22 utilize humane, cost-effective, and scientifically suit23 able nonanimal methods based on human biology will 

24 result in more progress toward understanding 

25 human diseases and their treatments and cures. It 


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1 will complete the vision that Congress set out in the 

2 National Institutes of Health Revitalization Act of 

3 1993 (Public Law 103–43), which has been thwart4 ed because of lack of oversight. 

5 SEC. 3. ANIMALS IN RESEARCH. 

6 Section 495 of the Public Health Service Act (42 

7 U.S.C. 289d) is amended— 

8 (1) in subsection (a)— 

9 (A) in paragraph (2)— 

10 (i) in the matter preceding subpara11 graph (A), by striking ‘‘paragraph’’ and in12 serting ‘‘subparagraph’’; and 

13 (ii) by redesignating subparagraphs 

14 (A) and (B) as clauses (i) and (ii), respec15 tively, and moving the margins of such 

16 clauses (as so redesignated) two ems to the 

17 right; 

18 (B) by redesignating paragraphs (1), (2) 

19 (as so amended), and (3) as subparagraphs (A), 

20 (B), and (C), respectively, and moving the mar21 gins of such subparagraphs (as so redesignated) 

22 two ems to the right; 

23 (C) in the matter preceding subparagraph 

24 (A) (as so redesignated), by striking ‘‘shall es25 tablish guidelines for the following:’’ and insertVerDate Sep 11 2014 07:19 Mar 07, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1024.IH H1024

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1 ing the following: ‘‘, with respect to all research 

2 conducted or supported by the National Insti3 tutes of Health, do the following: 

4 ‘‘(1) Establish and maintain animal care guide5 lines for the following:’’; and 

6 (D) by adding at the end the following: 

7 ‘‘(2) Establish a system of meaningful incen8 tives to encourage the use of existing humane and 

9 scientifically satisfactory nonanimal methods in re10 search proposals. 

11 ‘‘(3) Ensure that, before any research involving 

12 the use of animals is approved or performed all sci13 entifically satisfactory nonanimal methods for ob14 taining the results sought have been fully evaluated. 

15 ‘‘(4) Ensure that— 

16 ‘‘(A) research proposals are reviewed by at 

17 least one person who has expertise in nonanimal 

18 research methods; and 

19 ‘‘(B) reviewers of the research proposals 

20 have access to a reference librarian with exper21 tise in evaluating the adequacy of the searches 

22 for nonanimal methods described in the re23 search proposals. 

24 ‘‘(5) Establish and maintain research proposal 

25 guidelines for conducting thorough searches for nonVerDate Sep 11 2014 07:19 Mar 07, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1024.IH H1024

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1 animal alternatives to the use of animals for bio2 medical and behavioral research.’’; and 

3 (2) in subsection (c)(1)— 

4 (A) in subparagraph (A), by striking 

5 ‘‘and’’ at the end; and 

6 (B) by adding at the end the following: 

7 ‘‘(C) a statement of assurance that a sci8 entifically satisfactory nonanimal method of ob9 taining the result sought is not available; and’’. 

10 SEC. 4. NATIONAL CENTER FOR ALTERNATIVES TO ANI11 MALS IN RESEARCH AND TESTING. 

12 (a) ADDITION TO LIST OF INSTITUTES AND CEN13 TERS.—Section 401 of the Public Health Service Act (42 

14 U.S.C. 281) is amended— 

15 (1) by redesignating paragraph (25) as para16 graph (26); and 

17 (2) by inserting after paragraph (24) the fol18 lowing new paragraph: 

19 ‘‘(25) The National Center for Alternatives to 

20 Animals in Research and Testing.’’. 

21 (b) CONFORMING CHANGE TO NUMBER OF INSTI22 TUTES AND CENTERS.—Section 401(d)(1) of the Public 

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

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


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

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

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

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

5 ‘‘Subpart 6—National Center for Alternatives to 

6 Animals in Research and Testing 

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

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

9 after the date of enactment of the Humane and Existing 

10 Alternatives in Research and Testing Sciences Act of 

11 2022, the Secretary shall establish a National Center for 

12 Alternatives to Animals in Research and Testing (in this 

13 subpart referred to as the ‘National Center’) within the 

14 National Institutes of Health. The Center shall be headed 

15 by a director, who shall be appointed by the Secretary. 

16 ‘‘(b) PURPOSE.—The general purpose of the National 

17 Center shall be— 

18 ‘‘(1) developing, promoting, and funding alter19 natives to animal research and testing; and 

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

21 of animals used in federally funded research and 

22 testing. 

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

24 shall— 


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

2 federally funded researchers to incentivize the devel3 opment and qualification of nonanimal methods, 

4 such as advanced cell cultures or technology such as 

5 3D organoids, microphysiological systems, induced 

6 pluripotent adult stem cell models, in silico mod7 eling, advanced imaging systems, artificial intel8 ligence, and other innovative methods; 

9 ‘‘(2) train and inform scientists about the 

10 methods developed pursuant to paragraph (1); 

11 ‘‘(3) establish collaborations among research in12 stitutions so that scientists who lack resources (such 

13 as bioengineering and advanced bio-imaging equip14 ment) can develop and use methods developed pursu15 ant to paragraph (1); and 

16 ‘‘(4) collect information regarding the numbers 

17 of animals used in federally funded research and 

18 testing, and make such information available to the 

19 public in a timely manner.’’. 

20 SEC. 5. REPORTING BY FEDERALLY FUNDED RESEARCH 

21 ENTITIES ON NUMBERS OF ANIMALS USED IN 

22 RESEARCH AND TESTING. 

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

24 shall do the following: 


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1 (1) Not later than 2 years after the date of en2 actment of this Act, report to the National Center 

3 for Alternatives to Animals in Research and Testing 

4 and make publicly available— 

5 (A) the number of animals used by the 

6 covered reporting entity in federally funded re7 search and testing at facilities of the covered 

8 reporting entity, disaggregated by species; and 

9 (B) the total number of such animals that 

10 were bred or acquired by the covered reporting 

11 entity for research or testing purposes, 

12 disaggregated by species. 

13 (2) Every 2 years thereafter— 

14 (A) update the latest report of the covered 

15 reporting entity under this section and make 

16 publicly available such updated report to meas17 ure the progress of the covered reporting entity 

18 in reducing the number of animals used in fed19 erally funded research and testing; and 

20 (B) develop and submit to the National 

21 Center for Alternatives to Animals in Research 

22 and Testing and make publicly available a plan 

23 for reducing the numbers described in subpara24 graphs (A) and (B) of paragraph (1). 


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

2 National Center for Alternatives to Animals in Research 

3 and Testing shall establish a standardized process for sub4 mitting and updating reports and plans under subsection 

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

6 available. 

7 (c) DEFINITION.—In this section: 

8 (1) ANIMAL.—The term ‘‘animal’’ means any 

9 live, nonhuman vertebrate animal or cephalopod 

10 used or intended for use in research, research train11 ing, experimentation, or biological testing, or for re12 lated purposes. 

13 (2) COVERED REPORTING ENTITY.—The term 

14 ‘‘covered reporting entity’’ means— 

15 (A) any entity that— 

16 (i) receives Federal funds for research 

17 or testing; and 

18 (ii) uses animals in research and test19 ing; and 

20 (B) any Federal department or agency 

21 that uses animals in research or testing. 

Æ 


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