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Summary Information Format 

Category II Veterinary Biologics 

I. Introduction 

Category II Veterinary Biologics are live organisms that contain biotech-derived gene deletions 

and/or heterologous marker genes.

A. Provide a brief descriptive summary of the product:

B. Describe the intended use of the product:

1. Target species: 

2. Proposed label claim: 

3. Route of administration: 

4. Geographic area: 

II. Description of the Product

For a Category II SIF, the Backbone Biological Agent (BBA) is a live, replicative, or viable agent or 

vector used as the starting point for the biologic. The BBA itself could be modified or wild type prior 

to use. The Donor Biologic Agent (DBA) is the source of recombinant genes, and may also refer to 

inserted or synthetic sequences. For a Category II product, the only acceptable insert for expression 

would be a heterologous marker gene. The Regulated Biological Agent (RBA) is the final product, 

typically a live replicating, viable agent agent either synthesized or derived from the BBA via genetic 

modification. 

A. Backbone Biological Agent (BBA)

1. Describe the wild type or modified organism or material used for the BBA, where it 

was obtained or constructed, and cite the primary literature describing the BBA.

2. Characteristics of the BBA 

a. If the BBA has been modified from its wild-type parent, either via targeted 

manipulation or through in vitro passage, cite the primary literature, and/or 

include a flow diagram or explanation of the construction of the BBA. 

b. Describe how the BBA differs from the wild-type, including genetic and

phenotypic changes, and the methods and results useful for differentiating the 

BBA from its wild-type parent and other strains.

B. Donor Biological Agent (DBA) (or inserted marker sequences)

1. If nucleic acid was inserted into the BBA, identify the source of the nucleic acid 

whether obtained from a DBA or synthesized. If obtained from another organism 

(DBA), provide a thorough history of the origin and characteristics of the DBA 

organism.

2. Identify each nucleic acid sequence and the function of the genetic product. Cite 

literature as appropriate. 
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C. Regulated Biological Agent (RBA)

1. Identify where the final RBA was initially constructed and where the final product 

will be made, tested, and manufactured, and the biosafety level of the facilities.

2. Provide GenBank accession numbers or nucleic acid sequences in FASTA or 

FASTQ format (.txt files) for all relevant BBA, DBA, and RBA. Sequence files 

should contain actual, not theoretical, sequences for any new or altered genetic 

sequences, including insertion and flanking sequences. Whole genome sequence 

data should be provided as zipped FASTQ files. Contact CVB for guidance on 

electronic submission of large sequence files.

3. Provide a flow diagram for the laboratory construction of the RBA. Include the 

following: 

a. Backbone Biological Agent 

b. Donor Biological Agent or nucleic acid or gene 

c. All plasmids, shuttle vectors or kits and their source

d. Host cell lines used and source

e. Describe the selection techniques and methods used to construct the RBA. 

4. Describe the characterization of the RBA including the laboratory methods and 

criteria used to evaluate the RBA. Provide evidence that the genetic modifications

(deletions, substitutions, or marker genes) occurred as intended.

a. Describe and show the results of PCR, sequencing, or other genetic test that 

will discriminate between the BBA and RBA sequences. 

b. Describe the criteria for stability and purity of the RBA Master Seed (X) and 

highest passage thereof (X+n) desired for use in production.

c. Provide all detailed protocols and show characterization results of the 

expressed marker gene (if applicable), including but not limited to fluorescent 

antibody and Western blot testing of the BBA, Master Seed and X+n; 

including positive and negative controls. If appropriate, provide any 

purification or concentration steps/protocols used for characterization of the 

expressed/target antigen.

d. Provide a description of any genetic motifs that may have resulted due to the 

genetic modifications. Report any known motifs that may promote 

homologous recombination, insertion, or gene expression of existing or new 

open reading frames.

D. Safety Considerations

1. Provide the recommended CDC/NIH biosafety level for the BBA, DBA and RBA.

2. Describe, citing literature or internal data as appropriate, both any known virulence 

associated with and any previous safe use of the BBA (eg wild type), DBA

(inserted marker sequences), and RBA in:

a. Target animal species
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b. Non-target animal species

c. Humans

3. Clearly identify any antimicrobial resistance genes present or used to create the 

RBA, and whether these genes will be present in the final product.

4. Describe any expected or possible impact the final product could have on 

animal/human diagnostic testing, food testing, or disease surveillance programs. 

Include if a test to differentiate infected from vaccinated animals (DIVA) is 

available or possible.

III. Biological Properties of the RBA (Provide direct scientific evidence, including any 

relevant scientific publications, if available. Provide MailLog numbers of studies submitted 

to CVB where appropriate).

A. Describe the known phenotypic characteristics or effects of the genetic deletions or

substitutions on the RBA.

B. If applicable, describe whether the inserted reporter gene sequences enhance the virulence or 

survivability of the RBA in the host.

C. Describe the persistence and tissue tropism of the RBA in target and non-target animals.

D. Describe the potential for horizontal gene transfer or recombination of the RBA. Include any 

reason to believe that the potential for horizontal gene transfer or recombination is different 

in target and non-target animals. Include any contributions from the BBA and reporter gene 

sequence in the discussion.

E. Describe the shed/spread capabilities of the RBA. Include target and non-target animal 

species. Include any contributions to shed/spread capabilities that might be associated with 

attributes of the BBA and reporter gene sequence. 

F. Describe the environmental impact and survivability of the RBA. Include whether attributes 

of the BBA or reporter gene sequence enhance the ability to survive in the environment or 

increase resistance to therapeutic agents.