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TOPAZ and the 21st Century Cures Act

Credit: FDA.gov

Many of us have heard plenty about the 21st Century Cures Act (21CCA) at this point. For those who aren’t familiar yet, the 21CCA is a law that was enacted in 2016 authorizing billions of dollars in funding for, among many other things, significant efforts to eliminate bureaucratic red tape and reduce regulatory burden in research. This includes those in animal research.

After several years of NIH, USDA, and FDA working group meetings, interim reports, and open comment periods, the final report, entitled Reducing Administrative Burden for Researchers: Animal Care and Use in Research, was released on August 28th, 2019.

Although we still have some waiting to do, this is great news for us all! The agencies have compiled a list of proposed changes regarding semiannual inspections, protocol review processes, noncompliance and annual reporting procedures, and even harmonization efforts among OLAW, USDA, the DoD, and the VA. According to the report, progress is expected to be made over the next two years.

One exciting proposed change is “the development of a sample animal study protocol form” that focuses “on required protocol elements to ensure animal welfare and assist in IACUC review” (2016).  Between this and any other changes that the 21CCA is bound to yield, some changes to an organization’s Animal Care and Use Programs may be necessary.

With that said, TOPAZ is committed to remaining apprised of any industry changes and is here to support its customers through any of the changes thrown our way.  Visit Notice NOT-OD-19-136 for more information.

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