The 21st Century Cures Act, enacted in December 2016 as bipartisan legislation, aims to accelerate biomedical research and drug approval processes, address the opioid crisis and mental illness, and notably reduce administrative burden for researchers. Section 2034(d) mandates a review and revision of federal regulations and policies governing the care and use of laboratory animals, assigning the NIH as the lead agency, working in collaboration with the USDA and FDA. The primary objectives are to identify and eliminate inconsistencies, redundancies, and unnecessary duplications in existing regulations without compromising the integrity of research or the welfare of research animals.
To achieve these goals, a dedicated working group was convened in early 2017, which undertook a thorough review of relevant literature, stakeholder feedback—including over 19,000 public responses—and best practices from various professional organizations. Their efforts resulted in specific recommendations such as increased flexibility in inspection protocols, streamlined protocol reviews, modernized and harmonized reporting requirements, and enhanced coordination among federal agencies and external accrediting organizations. The plan also emphasizes stakeholder engagement, public transparency in policy revisions, support for training and best practice repositories, and ongoing efforts to balance effective animal welfare protections with minimizing administrative obstacles for researchers. Moving forward, NIH, USDA, and FDA are committed to implementing these reforms while continually seeking improvements that sustain both high-quality research and animal welfare standards.
