ABSTRACT
Specific regulatory agencies and requirements may vary with locale. At the time of publication, it is possible for a program in which mice are used for research or teaching to have no regulatory oversight. For example, if the institution receives no funds from the Public Health Service (PHS) for research, the use and care of any mice used would be exempt from the Public Health Service Policy on Humane Care and Use of Laboratory Animals (Public Health Service, 1996) and from enforcement of the standards of care described in the Guide for the Care and Use of Laboratory Animals (the Guide) (National Research Council, 2011). If the research or testing being conducted will not be used to support the approval process for drugs or medical devices intended for human or animal use, use of the mice would be exempt from the policies described in the Good Laboratory Practices for Nonclinical Studies (CFR 21, Food and Drugs). Likewise, if the facility is not accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC, International), it is exempt from the enforcement of the standards described in the Guide.
