OLAW Guidance Disclaimer Updated

Purpose

This notice provides an update to the National Institutes of health (NIH) Office of Laboratory Animal Welfare (OLAW) guidance disclaimer. The Health Research Extension Act of 1985, Public Law 99-158, Sec. 495, Animals in Research, (HREA) is the law that requires the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy).

Background

The PHS Policy applies to all PHS-conducted or supported activities involving live, vertebrate animals used – or intended for use – in research, research training, experimentation, or biological testing, or for related purposes. Currently, PHS components subject to the PHS Policy include the NIH, Biomedical Advanced Research and Progress Authority (BARDA), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA). The PHS Policy also applies to animal activities funded or supported by the National Aeronautics and Space Administration (NASA),National Science Foundation (NSF),and Department of Veterans Affairs (VA) through memoranda of understanding.

OLAW’s mission is to provide guidance and interpretation of the PHS policy. This aligns with PHS Policy Section V, which details OLAW’s responsibilities for “the general administration and coordination of” the PHS Policy, including “advising awarding units and awardee institutions concerning the implementation of this [PHS] Policy.”

The PHS Policy requires compliance with specific documents to ensure the humane care and use of animals in funded or supported activities.

When applicable,PHS Policy Section II also requires compliance with:

• The Animal Welfare Act and other federal statutes and regulations relating to animals
• State or local laws or regulations which impose more stringent standards for the care and use of laboratory animals

Additionally,PHS Policy Section II states that institutions in foreign countries receiving PHS support for activities involving animals must comply with PHS