Currently there are two opportunities for the biomedical research community to address the issue of regulatory/administrative burden. One involves the language contained in the 21st Century Cures Act (https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf) and the other the United States Department of Agriculture's (USDA) Request for Information (RFI) published in the July 17th Federal Register entitled “Identifying Regulatory Reform Initiatives” (https://www.regulations.gov/document?D=USDA-2017-0002-0001). This piece will review these opportunities.
The 21st Century Cures Act was signed into law December 13, 2016. The Act contains several features important to the biomedical research community, including measures intended to advance research and expedite approval for lifesaving cures. It also provides for the review of regulations and policies affecting researchers using animal models, with an emphasis on reducing administrative and regulatory burden. The key language appears on page 69 in Section 2034 of the Act entitled “Reducing the Administrative Burden for Researchers.” That language requires the Director of the National Institutes of Health (NIH) to collaborate with the USDA and Food and Drugs Administration (FDA) in a review of policies and regulations for the care and use of laboratory animals and where appropriate. It also requires the agencies to revise and reduce burden placed on investigators, while protecting research animals and maintaining the integrity and credibility of research findings. A report on these efforts is due within two years of the enactment of the law. The language in the Act specifies that the input of experts should be sought in this process and identifies three specific areas that the collaborating parties should address.
This is a preview of subscription content, access via your institution