CVB Notice 15-13: Alternative approach to hamster potency test for several Leptospira serogroups could reduce animal use by 50%

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CVB Notice 15-13: Alternative approach to hamster potency test for several Leptospira serogroups could reduce animal use by 50%

Contributor: Sherry Ward, AltTox

The Center for Veterinary Biologics (CVB) recently added CVB Notice 15-13, Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae, to its website: https://www.aphis.usda.gov/animal_health/vet_biologics/publications/notice_15_13.pdf

The purpose of this notice is to inform interested parties that the CVB will allow an exemption from the titration requirement in vaccination-challenge potency assays for Leptospira Serogroups Canicola and Icterohaemorrhagiae. Removal of the back-titration hamsters could reduce animal use by 50% when potency testing these two fractions.

According to 9 CFR 113.4, licensees and permittees must request an exemption to the codified hamster potency tests if they are interested in using an alternate approach. The Outline of Production must specify the titration exemption for each fraction. This policy is effective October 8, 2015.