CVB Update on In Vivo Potency Tests for 2 Leptospira Serogroups Could Reduce Animal Use

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CVB Update on In Vivo Potency Tests for 2 Leptospira Serogroups Could Reduce Animal Use

CVB NOTICE NO. 17-06: Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa

The Center for Veterinary Biologics (CVB) recently added CVB Notice 17-06 Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa to its website.

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 Pomona and Grippotyphosa. Removal of the back-titration hamsters could reduce animal use by 50 percent 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. The Outline of Production must specify the backtitration exemption for each fraction. This policy is effective at the receipt of this notice.

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