21st Century Cures Act: Update on Implementation

Date: Thursday, March 11, 2021
Time: 3:00PM ET - 4:00PM ET
Location: Virtual
Cost: Free
This Event is Recorded: The recording and resources will be available 7-10 business days after the event
Hosted by: Office of Laboratory Animal Welfare (OLAW)

Event Overview:

Description:

In this prerecorded webinar, NIH, USDA, and FDA representatives provide updates on the agencies’ progress in implementing the recommended measures of the 21st Century Cures Act.

The 21st Century Cures Act, Section 2034(d), directed federal agencies to “complete a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and the protection of research animals.” A report (PDF) released in 2019 by a Working Group of NIH, USDA, and FDA representatives detailed the agencies’ plans to comply with the Act, including changing regulations and policy, improving coordination and harmonization, and developing new training and resources.

Audience:

The program is tailored to IACUC staff, IACUC members, IOs, veterinarians, investigators, compliance personnel, animal care staff, and others involved in animal programs.

Note

While this information was accurate at the time presented, policies and procedures change over time. Past webinars may not contain the most current guidance. Please note, do not rely on webinars and associated materials as definitive compliance guidance for your specific situation. For compliance questions, please contact OLAW directly.

Update March 2024: USDA has provided updates to semiannual inspection requirements for USDA-covered species. Updates can be found in NOT-OD-24-075 and NOT-OD-24-076

Event Resources

Presenter(s):

Pat Brown, M.S., VMD
Director
Office of Laboratory Animal Welfare (OLAW)
Office of the Director (OD)
NIH, HHS
Read Bio
Pat Brown
Betty Goldentyer, D.V.M
Deputy Administrator
Animal Care
Animal and Plant Health Inspection Service (APHIS)
USDA
Read Bio
Betty Goldentyer
Brianna Skinner, D.V.M, M.P.H
Senior Regulatory Veterinarian
Office of Counterterrorism and Emerging Threats
Office of the Chief Scientist
FDA
Read Bio
Brianna Skinner
<p>CAPT Brianna Skinner is a Commissioned Corps officer in the U.S. Public Health Service who has also served in the U.S. Army Veterinary Corps. As a uniformed service officer, she has proudly served her country within the continental United States and abroad on several humanitarian and disaster response missions. She is currently assigned to the Office of Countermeasures and Emerging Threats (OCET), Office of the Chief Scientist at the U.S. Food and Drug Administration (FDA) where she currently serves as a Senior Regulatory Veterinarian and animal model expert for the administration of policies to facilitate the availability of safe and effective medical countermeasures against chemical, biological, radiological, nuclear agents and emerging threats. CAPT Skinner is the Chair for FDA’s Animal Welfare Council and serves as the CoLead of FDA’s One Health Steering Committee’s operational activities and is the OCS One Health representative. Prior to transferring to the FDA, she worked at the Centers for Disease Control and Prevention for over eleven years leading clinical operations within the vivarium, consulting with principal investigators on animal care and use with infectious disease research from biosafety levels 1 – 4, and training laboratory animal veterinarians. She earned her Doctor of Veterinary Medicine degree from Tuskegee University, her Master’s in Public Health from Benedictine University, and is board certified in laboratory animal medicine with the American College of Laboratory Animal Medicine.</p>

Contact:

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