Washington Update

21st Century Cures Working Group Releases Final Administrative Burden Report

By: Naomi Charalambakis
Wednesday, October 9, 2019

On August 28, the National Institutes of Health (NIH), U.S. Department of Agriculture (USDA), and Food and Drug Administration (FDA) released the final report, “Reducing Administrative Burden for Researchers: Animal Care and Use in Research.” The report is in accordance with Title II, Section 2034(d) of the 21st Century Cures Act, which required the three agencies to convene a working group and identify and revise inconsistent policies regarding the care and use of laboratory animals.

In the report, the working group outlines upcoming modifications to existing policies, including:

  • Enhancement of existing options to streamline protocol review
  • Elimination of USDA’s three-year registration renewal
  • Harmonization of USDA and NIH policies to require triennial review of planned animal activities rather than annual review.

Additionally, the report indicates the agencies’ plans to spend the next two years completing their review and beginning implementation. In a letter submitted to NIH and members of the working group, FASEB acknowledged that, while the report recommendations are steps in the right direction, they are an inadequate response to the charge set forth by the 21st Century Cures Act.

In an effort to mitigate the risks of ongoing confusion among institutional leaders concerning animal research guidelines, FASEB offered two interim actions for the working group’s consideration:

  • Publication of a Frequently Asked Questions (FAQs) document to address and clarify common inquiries, including those submitted to FASEB during its March 2019 webinars on the topic
  • Regular posting of an NIH Office of Laboratory Animal Welfare blog, consistent with those of other institutes and centers.