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Risk Analysis for Veterinary Biologics |
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The Center for Veterinary Biologics uses risk analysis procedures to evaluate: (i) license applications for new live conventionally derived and biotechnology-derived veterinary biologics, and (ii) proposals to import veterinary biologics into the United States. The following Summary Information Formats (SIFs) and Risk Assessment (RA) Outline identify the relevant information that should be evaluated in Veterinary Biologics risk analyses. See Veterinary Services Memorandum 800.205 (PDF 19KB) for additional guidance.
Summary Information Format for Conventionally Derived Live Veterinary Biologics (PDF 14KB)
This SIF is designed to identify the appropriate information that should be provided to properly characterize the vaccine microorganisms for conventionally derived live vaccines. The characterization of the vaccine microorganism is based on its microbiological and biological properties, and those of the parental microorganism from which the vaccine strain was derived.
SIF Category I Veterinary Biologics (PDF 16KB)
| Subcategories | |
| I-A-1 | non-replicating recombinant antigens--therapeutic/prophylactic use |
| I-A-2 | non-replicating recombinant antigens--diagnostics |
| I-B-1 | monoclonal antibodies--therapeutic/prophylactic use |
| I-B-2 | monoclonal antibodies--diagnostics |
| I-C-1 | synthetic peptides --therapeutic/prophylactic use |
| I-C-2 | synthetic peptides --diagnostics |
| I-D-1 | nucleic acid-mediated--therapeutic/prophylactic use |
| I-D-2 | nucleic acid-mediated--diagnostics |
It is not anticipated that inactivated microorganisms will pose a threat to the environment. Accordingly, the risk analysis process is used to ensure that the biotechnology-derived microorganism is properly characterized and inactivated, rather than to evaluate proposed environmental releases of inactivated products. Example of Category I SIF
SIF Category II Veterinary Biologics (PDF 19KB)
Category II biologics include biotechnology-derived live vaccines containing gene deletions and\or heterologous marker genes. Example of Category II SIF
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