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Summary Information Format 

Category I Veterinary Biologics 

I. Introduction 

Category I Veterinary Biologics are nonviable products such as subunits, antibodies, nucleic acids, or 

other recombinant agents. Live organisms may be used in the development and manufacturing, but 

there are no live organisms in the final product. Since platform and prescription products are 

currently required to be Category I biologics, this SIF also is used in place of the previous Category 

IV SIF.

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 I SIF, the Backbone Biological Agent (BBA) is a replicative, viable or active vector 

or expression system used for manufacturing or delivery of the biologic. The Donor Biologic Agent 

(DBA) is the source of recombinant genes if applicable, any may also refer to inserted or synthetic 

sequences. The Regulated Biological Agent (RBA) is the final product, typically a non-replicating, 

nonviable, inactive, or killed agent either synthesized or derived from a BBA via genetic 

modification. 

A. Backbone Biological Agent (BBA)

1. Describe the 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.

B. Donor Biological Agent (DBA) (or inserted 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.
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2. Identify each nucleic acid sequence and the function of the genetic product. Cite 

literature as appropriate. 

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 

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/target antigen, including but not limited to fluorescent antibody and 

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

and negative controls. 

i. 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.

e. Describe the nature of the RBA, harvest or inactivation procedures, or test 

procedures that ensure lack of any live organisms in the final product.

D. Safety Considerations

1. Provide the recommended CDC/NIH biosafety level for the BBA, DBA and RBA.
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2. Describe, citing literature or internal data as appropriate, both any known virulence 

associated with and any previous safe use of the BBA, DBA (inserted sequences), 

and RBA in:

a. Target animal species

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.