USDA. Animal and Plant Health Inspection Service (APHIS). Center for Veterinary Biologics (CVB).
- Guidance for obtaining an exemption to the requirement for testing Leptospira bacterins for potency in hamsters, Veterinary Services (VS) Memorandum No. 800.102 (2013) -- provides information on alternative in vitro potency assays (SAM) and on reagents available from the Center for Veterinary Biologics (CVB). Use of ELISA is optional. Firms are to obtain an exemption from CVB before using the ELISA. Firms must validate the potency assays for their products and submit data to CVB for acceptance.
- Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Canicola and Icterohaemorrhagiae, CVB Notice #15-13 (2015) -- provides biologic licensees, permitees and applicants the option to remove back-titration hamsters from in vivo potency tests for Leptospira serogroups icterohaemorrhagiae and canicola. CVB would allow an exemption from the titration requirement in vaccination-challenge potency assays for these serogroups Removal of the back-titration hamsters could reduce animal use by 50% when potency testing these two fractions.
- Option to Remove Back-titration Hamsters from In Vivo Potency Tests for Leptospira Serogroups Pomona and Grippotyphosa, CVB Notice #17-06 (2017) -- provides biologic licensees, permitees and applicants the option to remove back-titration hamsters from in vivo potency tests for Leptospira serogroups pomona and grippotyphosa. CVB would allow an exemption from the titration requirement in vaccination-challenge potency assays for these serogroups. Removal of the back-titration hamsters could reduce animal use by 50% when potency testing these two fractions.
- Leptospira Bacterin Potency Testing regulations (9 CFR §113.101- 113.105)