The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics recently added Veterinary Services (VS) Memorandum 800.116 Target Animal Safety Testing Exemption to its website. All VS Memoranda are available at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/biologics-regulations-and-guidance/ct_vb_vs_memos.
VS Memorandum No. 800.116, signed in August 2017, replaces an earlier version issued in July 2013. The memorandum provides guidance to licensed firms on requesting an exemption under title 9, Code of Federal Regulations (9 CFR), part 113.4, to target animal safety testing as required for testing of live and inactivated vaccines and antibody products. Such exemptions can reduce animal use in facilities that have documented consistency in manufacturing processes and product safety.