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Risk Analysis and Summary

Information Formats 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 for additional

guidance.

Summary Information Format for Conventionally Derived Live Veterinary Biologics

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. To be considered conventional and not

derived by recombinant means under NEPA restrictions, the parental history and

path to attenuation should be included.

SIF Category I Veterinary Biologics (163.51 KB)
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.

SIF Category II Veterinary Biologics (166.1 KB)

Category II biologics include biotechnology-derived live vaccines containing gene

deletions and\or heterologous marker genes.

SIF Category III Veterinary Biologics (165.7 KB)

Subcategories

III-A live vectored organisms

III-B-1 transgenic plant-based--therapeutic/prophylactic use

III-B-2 transgenic plant-based--diagnostics

As of December 2021, please utilize the revised Category I SIF (163.51 KB) in place

of the Category IV SIF.

Risk Assessment Outline For Use in Preparing Risk Analyses For BiotechnologyDerived Products (56.78 KB) (July 9, 2015)

When submitting a Risk Analysis to the CVB for prelicense evaluation of a Category I,

II, III, or IV biotechnology-derived product, the Risk Analysis should contain the most

current version of the SIF and a Risk Assessment based on safety characteristics of
the vaccine.

Summary Information Format for Environmental Releases (15.17 KB)

Risk analyses for new live conventionally derived and biotechnology-derived

veterinary biologics need to include environmental release assessments, which

evaluate the safety characteristics of the vaccine microorganism within the context

of the target environment. This SIF identifies the information that should be included

in release assessments.

Summary Information Format for the Importation of Veterinary Biological Products

into the United States (173.75 KB)

The Veterinary Biologics risk analysis model for importing veterinary biologics

centers on the risk of introducing foreign animal disease into the United States

through the importation of a contaminated veterinary biological product. This

requires a thorough evaluation of all potential sources of contamination during the

development and manufacture of the product. This SIF identifies the information

regarding the facilities, reagents, production procedures, and testing procedures

that should be evaluated.