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Implementation of the Revised International Guiding Principles for Biomedical Research Involving Animals

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The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the revised International Guiding Principles for Biomedical Research Involving Animals (“Guiding Principles”). The NIH is seeking input from the public on any concerns they may have regarding the revised Guiding Principles.


Public concerns regarding the revised Guiding Principles must be submitted electronically at​grants/​rfi/​rfi.cfm?​ID=​35 by September 30, 2013 in order to be considered.

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Office of Laboratory Animal Welfare, Office of Extramural Research, National Institutes of Health, Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892-7982, phone: 301-496-7163, email:

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I. Background

The NIH Office of Laboratory Animal Welfare (OLAW) oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 (​grants/​olaw/​references/​hrea1985.htm) and the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy;​grants/​olaw/​references/​phspol.htm). The PHS Policy requires that institutions have an approved Animal Welfare Assurance before conducting activities involving live vertebrate animals. Institutions outside the United States that receive PHS funding are required to have a Foreign Assurance (​grants/​olaw/​sampledoc/​foreign.htm) that commits the institution to follow the International Guiding Principles for Biomedical Research Involving Animals (“Guiding Principles”). The Guiding Principles were revised in December 2012 by a partnership between the Council for International Organizations for Medical Science (CIOMS) and the International Council for Laboratory Animal Science (ICLAS).

PHS-Assured institutions outside the United States are encouraged to adopt the revised Guiding Principles as soon as possible, and full implementation is expected after October 1, 2013. OLAW will confirm an institution's adoption of the Guiding Principles at the next renewal of the Foreign Assurance.

II. Electronic Access

The December 2012 revision of the Guiding Principles is available for download at​grants/​olaw/​Guiding_​Principles_​2012.pdf (PDF).

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Dated: August 19, 2013.

Francis S. Collins,

Director, National Institutes of Health.

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[FR Doc. 2013-20740 Filed 8-23-13; 8:45 am]