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Comments Welcomed on the Draft Report Recommending How to Reduce Administrative Burden in Research with Laboratory Animals: A Next Step in Implementing the 21st Century Cures Act

The 21st Century Cures Act requires federal agencies to “review applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research finding and protection of research animals.” This past March we requested feedback from the public on ways to reduce regulatory burden while also maintaining the highest standards for protecting animal welfare and scientific integrity. You responded with constructive and helpful feedback with more than 19,000 comments. Generally, many responses supported the actions initially proposed in the request, but they were balanced with concerns from animal advocacy and other groups.

A working group of animal welfare experts from NIH, the US Department of Agriculture and the Food and Drug Administration thoroughly reviewed and carefully considered all public comments. The working group integrated their analysis of the public comments with their previous studies of relevant published reports, survey findings from diverse animal welfare organizations, and feedback provided by engaged stakeholders at listening sessions during professional meetings. They have now released a draft report (see also the Federal Register Notice), which includes proposed actions to address inconsistent, overlapping, or unnecessarily duplicative laboratory animal welfare regulations and policies (NOT-OD-19-028).

Today, we again seek your thoughts. Scientists, research institutions, animal welfare advocacy groups, professional societies, and the public are invited to comment on the recommendations outlined in the draft report. Your comments must be submitted electronically here over the next sixty days until February 5, 2019.

The draft report outlines areas in which we can make oversight more efficient and reduce burden without compromising animal welfare or scientific integrity: these areas include Institutional Animal Care and Use Committee Inspections, protocol reviews, and annual progress reporting. The draft report recommends increased coordination across federal agencies by refining guidance on federal standards and harmonizing agency requirements, training, and resources.

We appreciate your thoughtful and substantive comments. Your views on the actions proposed will continue to help ensure NIH promotes the highest level of well-being for laboratory animals, scientific integrity, public accountability, and social responsibility in the conduct of science.

This is not the end of the story. Together with our federal partners, we will continue to identify redundancies in federal requirements and to harmonize policies which affect laboratory animal welfare. Moreover, we will continue to provide federal oversight to ensure that when animal research is necessary, the animals are responsibly cared for and humanely used in federally funded studies.

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