Viruses, Serums, Toxins, and Analogous Products; Rabies Vaccine, Killed Virus and Rabies Vaccine, Live Virus

Resumo

We are proposing to amend the standard requirements for establishing the immunogenicity of Rabies Vaccine, Killed Virus and Rabies Vaccine, Live Virus. The amendment would change and clarify alternate test procedures which may be used in animals other than carnivores. Under the proposed rule, when a reduced number of challenge animals is used in a rabies immunogenicity test, all vaccinates must survive challenge. If one or more of the challenged vaccinates die of rabies, all of the remainder of the vaccinates would have to be challenged or the test would be deemed unsatisfactory and terminated. This proposed action would correct a problem associated with rabies immunogenicity tests in the regulations and make other changes deemed necessary for clarity and consistency.