Appendix C 
Public Health Service Policy on 
Humane Care and Use of Laboratory 
Animals by Awardee Institutions 
The following is reprinted from U.S. Department of 
Health and Human Services , Public Health Service , Na- 
tional Institutes of Health , "Laboratory Animal Wel- 
fare,” NIH Guide for Grants and Contracts 14(8), June 
25, 1985. 
Introduction 
It is the policy of the Public Health Service (PHS) to 
require institutions to establish and maintain proper 
measures to ensure the appropriate care and use of 
all animals involved in research, research training and 
biological testing activities (hereinafter referred to as 
activities) supported by the PHS. The PHS endorses 
the "U.S. Government Principles for the Utilization and 
Care of Vertebrate Animals Used in Testing, Research 
and Training” developed by the Interagency Research 
Animal Committee (IRAC). This policy is intended to 
implement and supplement those Principles. 
Applicabili ty 
This policy is applicable to all PHS -approved activities 
involving animals, whether the activities are performed 
at an awardee institution or any other institution and 
conducted in the United States, the Commonwealth 
of Puerto Rico, or any territory of possession of the 
United States. Institutions in foreign countries receiv- 
ing PHS support for activities involving animals shall 
comply with this policy, or provide evidence to the 
PHS that acceptable standards for humane care and 
use of the animals in PHS -supported activities will be 
met. No PHS support for an activity involving animals 
will be provided to an individual unless that individ- 
ual is affiliated with or sponsored by an institution 
which can and does assume responsibility for compli- 
ance with this policy for PHS -supported activities, or 
unless the individual makes other arrangements with 
the PHS. This policy does not affect applicable state 
or local laws or regulations which impose more strin- 
gent standards for the care and use of laboratory ani- 
mals. All institutions are required to comply, as appli- 
cable, with the Animal Welfare Act, and other Federal 
statutes and regulations relating to animals. 
Definitions 
A. Animal 
Any live, vertebrate animal used or intended for 
use in research, research training, experimenta- 
tion or biological testing or for related purposes. 
B. Animal Facility 
Any and all buildings, rooms, areas, enclosures, 
or vehicles, including satellite facilities, used for 
animal confinement, transport, maintenance, breed- 
ing or experiments inclusive of surgical manipula- 
tion. A satellite facility is any containment outside 
of a core facility or centrally designated or man- 
aged area in which animals are housed for more 
than 24 hours. 
C. Animal Welfare Act 
Public Law 89-544, 1966, as amended, (P.L. 91- 
579 and P.L. 94-279) 7 U.S.C. 2131 et seq. Imple- 
menting regulations are published in the Code of 
Federal Regulations (CFR), Title 9, Subchapter A, 
Parts 1, 2, 3 and 4, and are administered by the 
U.S. Department of Agriculture. 
D. Animal Welfare Assurance or Assurance 
The documentation from an awardee or a pro- 
spective awardee institution assuring institutional 
compliance with this policy. 
E. Guide 
Guide for the Care and Use of Laboratory Ani- 
mals, DHEW, NIH Pub. No. 78-23, 1978 edition or 
succeeding revised editions. 
F. Institution 
Any public or private organization, business, or 
agency (including components of Federal, state and 
local governments). 
G. Institutional Official 
An individual who has the authority to sign the 
institution’s Assurance, making a commitment on 
behalf of the institution that the requirements of 
this policy will be met. 
H. Public Health Service 
The Public Health Service includes the Alcohol, 
Drug Abuse, and Mental Health Administration, the 
Centers for Disease Control, the Food and Drug 
Administration, the Health Resources and Services 
Administration, and the National Institutes of 
Health. 
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