The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) regularly seeks public comment on drafts of proposed guidance documents concerning all aspects of veterinary vaccines production, testing, and distribution. Draft Notice 465, which is currently available for comment, provides proposed guidance on the use of humane endpoints and methods in animal testing of biological products. The draft document includes specific guidance regarding the use of humane endpoints in biological products testing, including guidance on humane endpoints for the rabies challenge test. The draft guidance also strongly encourages the use of anesthesia for intracerebral inoculation of mice during rabies vaccine testing.
The draft guidance incorporates recommendations for refinement of rabies vaccine testing made by participants at the October 2011 NICEATM-ICCVAM workshop on alternative methods for rabies vaccine potency testing. Information about the workshop is available on the NICEATM-ICCVAM website. A summary of the workshop is posted here.
Comments on the draft proposed guidance document should be submitted by April 23, 2012, via email to firstname.lastname@example.org. Draft proposed CVB guidance documents and additional information about submitting comments are available on the USDA website above.