Viruses, Serums, Toxins, and Analogous Products; Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus
other · US Department of Agriculture · Rule · Published 1996-12-26 · Effective 1997-01-27 · 61 FR 67929
Document
Document number
96-32725
Federal Register citation
61 FR 67929
CFR reference
9 CFR 113
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Agriculture
Publication date
1996-12-26
Effective date
1997-01-27
USDA docket
Docket No. 93-128-2
Abstract
We are amending the standard requirement for Encephalomyelitis Vaccine, Eastern and Western, Killed Virus, by specifying requirements for killed Venezuelan equine encephalomyelitis vaccines and revising the standard potency test for Eastern and Western equine encephalomyelitis vaccines. The amendments require the use of Vero 76 cells in the test to evaluate the potency of Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus, and establish minimum antibody titers which must be elicited by each of the indicated fractions, as determined by a plaque reduction, serum neutralization assay in which Vero 76 cells are used.