The 21st Century Cures Act doesn’t impact the U.S. Department of Agriculture (USDA) as much as the NIH Office of Laboratory Animal Welfare, but it does require USDA to take steps to reduce the regulatory burden on institutions conducting research involving animals that fall under the agency’s purview, a top official said.
Elizabeth Theodorson, assistant deputy administrator of animal care at the USDA Animal and Plant Health Inspection Service, told attendees at a recent webinar that USDA is implementing the act to cut red tape. Specifically, she said, the agency:
Removed the requirement for research facilities to update their registration every three years.
Clarified conditions for cancellation to require submission of a written request to the USDA deputy administrator.
Eliminated inactive status so that a facility will either be registered or unregistered.
USDA also changed the rules for continuing review of animal activities, Theodorson said. Previously, continuous review of animal activities was required not less than annually after institutional animal care and use committee approval. The new rules require a complete review of animal activities every three years. This complies with the 21st Century Cures Act requirement to reduce the burden on institutions by harmonizing the rules with Public Health Service policy, she said.
Finally, Theodorson said, annual reports no longer must be signed by the CEO or the institutional official. This expedites processing and allows facilities to designate their own signatories, she said. However, she noted that the annual report still must be signed and won’t be processed without a signature.