scientifically suitable non-animal methods are avail-
able. 
(6) Under the system of oversight established 
by the Animal Welfare Act (Public Law 89–544), re-
searchers are supposed to consider alternatives to 
animal use or painful procedures and should not un-
necessarily duplicate previous experiments. However, 
oversight is generally weak and little heed is paid to 
the use of non-animal methods or the avoidance of 
duplication, thereby unnecessarily subjecting animals 
to pain, suffering, and death. 
(7) A system of active incentives is needed to 
encourage researchers to utilize humane, cost-effec-
tive, and scientifically suitable non-animal methods. 
SEC. 3. ANIMALS IN RESEARCH. 
Section 495 of the Public Health Service Act (42 
U.S.C. 289d) is amended to read as follows: 
‘‘SEC. 495. ANIMALS IN RESEARCH. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director of NIH, shall, with respect to all research 
conducted or supported by the National Institutes of 
Health, do the following: 
‘‘(1) Establish a system of meaningful incen-
tives to encourage the use of existing humane and 
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scientifically satisfactory non-animal methods in re-
search proposals. 
‘‘(2) Ensure that, before any research involving 
the use of animals is approved or performed— 
‘‘(A) all scientifically satisfactory non-ani-
mal methods for obtaining the results sought 
have been fully evaluated; and 
‘‘(B) a detailed explanation and an anal-
ysis of the harms and benefits of such use of 
animals have been completed. 
‘‘(3) Ensure that— 
‘‘(A) research proposals are reviewed by at 
least one person who has expertise in non-ani-
mal research methods; and 
‘‘(B) reviewers of the research proposals 
have access to a reference librarian with exper-
tise in evaluating the adequacy of the searches 
for non-animal methods described in the re-
search proposals. 
‘‘(4) Establish and maintain research proposal 
guidelines for the following: 
‘‘(A) Conducting thorough searches for 
non-animal alternatives to the use of animals 
for biomedical and behavioral research. 
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‘‘(B) 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 suf-
fering, pain, and distress are justified by the 
expected outcomes, taking into account ethical 
considerations and the expected benefits to 
human beings, animals, or the environment. 
‘‘(5) Establish and maintain animal care guide-
lines for the following: 
‘‘(A) The proper care of animals to be 
used in biomedical and behavioral research. 
‘‘(B) The proper treatment of animals 
while being used in such research. Guidelines 
under this paragraph shall require— 
‘‘(i) the appropriate use of tranquil-
izers, analgesics, anesthetics, paralytics, 
and euthanasia for animals in such re-
search; and 
‘‘(ii) appropriate pre-surgical and 
post-surgical veterinary medical and nurs-
ing care for animals in such research. 
Such guidelines shall not be construed to pre-
scribe methods of research. 
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‘‘(C) The organization and operation of 
animal care committees in accordance with sub-
section (b). 
‘‘(b) ANIMAL CARE COMMITTEES.— 
‘‘(1) IN GENERAL.—The guidelines under sub-
section (a)(5)(C) shall require animal care commit-
tees at each entity which conducts biomedical and 
behavioral research with funds provided under this 
Act (including the National Institutes of Health and 
the national research institutes) to assure compli-
ance with the guidelines established under sub-
section (a)(5). 
‘‘(2) APPOINTMENT OF MEMBERS.—Each ani-
mal care committee shall— 
‘‘(A) be appointed by the chief executive 
officer of the entity for which the committee is 
established; 
‘‘(B) be composed of not fewer than three 
members; and 
‘‘(C) include at least one individual who 
has no association with such entity and at least 
one doctor of veterinary medicine. 
‘‘(3) REQUIREMENTS.—Each animal care com-
mittee of a research entity shall— 
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‘‘(A) review the care and treatment of ani-
mals in all animal study areas and facilities of 
the research entity at least semiannually to 
evaluate compliance with applicable guidelines 
established under subsection (a)(5) for appro-
priate animal care and treatment; 
‘‘(B) keep appropriate records of reviews 
conducted under subparagraph (A); and 
‘‘(C) for each review conducted under sub-
paragraph (A), file with the Director of NIH at 
least annually— 
‘‘(i) a certification that the review has 
been conducted; and 
‘‘(ii) reports of any violations of the 
guidelines under subsection (a)(5) or as-
surances required under paragraph (1) 
which were observed in such review and 
which have continued after notice by the 
committee to the research entity involved 
of the violations. 
‘‘(4) MINORITY
VIEWS.—Reports filed under 
paragraph (3)(C) shall include any minority views 
filed by members of the committee. 
‘‘(c) APPLICATIONS AND CONTRACTS.— 
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‘‘(1) CONTENTS.—The Director of NIH shall 
require each applicant for a grant, contract, or coop-
erative 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— 
‘‘(A) assurances satisfactory to the Direc-
tor of NIH that— 
‘‘(i) the applicant meets the require-
ments under paragraphs (2), (3), (4), and 
(5) of subsection (a) and has an animal 
care committee which meets the require-
ments of subsection (b); and 
‘‘(ii) scientists, animal technicians, 
and other personnel involved with animal 
care, treatment, and use by the applicant 
have available to them instruction or train-
ing in— 
‘‘(I) the humane practice of ani-
mal 
maintenance 
and 
experimen-
tation; and 
‘‘(II) the concept, availability, 
and use of research or testing meth-
ods that replace the use of animals, 
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limit the use of animals, or limit ani-
mal distress; 
‘‘(B) a statement of the reasons for the 
use of animals in the research to be conducted 
with funds provided under such grant or con-
tract; 
‘‘(C) a statement of assurance that a sci-
entifically satisfactory non-animal method of 
obtaining the result sought is not available; and 
‘‘(D) 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 suffering, pain, 
and distress is justified by the expected out-
comes, taking into account ethical consider-
ations and the expected benefits to human 
beings, animals, or the environment. 
‘‘(2) REGULATORY PROCESS.—Notwithstanding 
subsection (a)(2) of section 553 of title 5, United 
States Code, regulations under this subsection shall 
be promulgated in accordance with the notice and 
comment requirements of such section. 
‘‘(d) SUSPENSION OR REVOCATION.—If the Director 
of NIH determines that— 
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‘‘(1) the conditions of animal care, treatment, 
or use in an entity which is receiving a grant, con-
tract, or cooperative agreement involving research on 
animals under this title do not meet applicable 
guidelines established under subsection (a)(5); 
‘‘(2) the entity has been notified by the Direc-
tor of NIH of such determination and has been 
given a reasonable opportunity to take corrective ac-
tion; and 
‘‘(3) no action has been taken by the entity to 
correct such conditions, 
the Director of NIH shall suspend or revoke such grant, 
contract, or cooperative agreement under such conditions 
as the Director determines appropriate. 
‘‘(e) PROTECTION OF CERTAIN INFORMATION.—No 
guideline or regulation promulgated under subsection 
(a)(5) or (c) may require a research entity to disclose pub-
licly trade secrets or commercial or financial information 
which is privileged or confidential.’’. 
Æ 
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