Laboratory Animal Welfare: Coordination and Harmonization of Regulations and Policies; NIH Notice and Request for Comments

The 2016 National Academies report, Optimizing the Nation’s Investment in Academic Research, recommended that Congress direct OMB to convene representatives from federal agencies and the research community to assess the feasibility and utility of establishing a unified federal approach to develop, promulgate, and manage policies and regulations pertaining to the care and use of research animals, a. [...] In making this determination, the IACUC shall confirm that the research project will be conducted in accordance with the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is presented. [...] In addition to the proposed actions outlined above, we ask that NIH, USDA and FDA consider the following recommendations made in the FASEB-AAMC-COGR-NABR report, many of which were previously made in the 1999 NIH Initiative to Reduce Regulatory Burden and other reports: “NIH and other federal agencies involved in the review of regulations and policies for the care and use of laboratory animals m. [...] The grant application is often outdated by the time the research study is submitted for IRB review and contains detailed information about the costs of a study, personnel, and administrative issues that go beyond the mission of the IRB to protect human subjects. [...] “Revise USDA Animal Care Policy #14 to reflect the language in AWA §2143 and AWR §2.31(d)(1)(x)(A-C), allowing approval of multiple survival operative procedures at the discretion of the IACUC and as justified for scientific and animal welfare reasons.” This will enhance the community’s efforts to reduce the number of animals involved in research.