Guidance to Industry: Preparing Supporting Summaries for Single-Tier Effectiveness Statements

September 1, 2020 Page 4 of 10

V. ISS template

A. First page

The first page of the ISS template contains a table with identifying information that will not be 

included when this ISS is incorporated into a PCS by the CVB. PCSs will have their own cover 

page containing appropriate identifying information for the Product. To facilitate computerized 

assembly of the PCS by the CVB, the table on page 1 of an ISS template must be the only item 

on Page 1 of the completed document. 

First page table:

Original Establishment 

Number

Enter the Est # from which the study was submitted, even if (as 

in the case of split manufacture or acquisition/merger) the study 

may pertain to another Establishment’s final-use product

Original Product Code Enter the original code(s) of the product under which the study 

was submitted. 

Current Product Codes Enter the current Est # if it is different from the original Est #. 

Enter any current codes to which the study applies. We realize 

this may not agree with the original code if the product has been 

subject to acquisitions and mergers. 

Study Identifier The CVB strongly encourages applicants to create a unique ID 

for studies. Enter the identifier, if one was created. The CVB 

recognizes there may not be a unique ID for certain historical

studies. 

This is an excerpt from the Guidance 

document that specifically applies to ISS 

Templates provided for your convenience.
Guidance to Industry: Preparing Supporting Summaries for Single-Tier Effectiveness Statements

September 1, 2020 Page 5 of 10

Date Study Submitted Enter the date the efficacy/safety study was submitted to the 

CVB (not the submission date for the Individual Study Summary 

if it is submitted after the study was reviewed)

CVB Mail Log ID

containing study

For historical studies, the CVB Mail Log (ML) ID of the full 

study submission will differ from the ML assigned to the 

individual study summary because they are being submitted 

separately. In many cases, the ML ID assigned to the full study 

report may not be known to the firm. The CVB may add this 

information later if we can trace the ML # in our records. Some 

studies may pre-date any kind of CVB Mail Log. 

B. Subsequent page(s)

The following table, to begin on page 2 of a completed ISS, will appear in PCSs.

Study Type Enter Efficacy or Safety.

Pertaining to • Enter the agent against which efficacy is being

demonstrated. For influenza products, include the

influenza strain by WHO nomenclature (e.g.,

A/California/04/2009(H1N1).

• For BVD products, enter the type (e.g. Type 1, Type 2).

• For PCV products, enter the genotype (e.g. 2).

Enter ALL for safety studies. 

Study Purpose Be succinct and non-technical, using plain language. 

Examples: 

• To demonstrate efficacy against diarrhea in piglets

nursing vaccinated sows

• To demonstrate efficacy against respiratory disease one

year after vaccination

• To demonstrate safety under field conditions

• To demonstrate safety in pregnant animals

Product Administration Include the number of doses, interval between doses, and the 

route of administration. 

If the product administered is a platform product, include the 

identity of the inserted gene for the serial used in the study. 

Study Animals Include the animal species, age at first product administration, 

and number of animals per treatment group. 

For efficacy studies, the number of animals per treatment group 

should be the number included in the final study analysis. 

For field safety trials, all animals enrolled in the study should be 

represented. State an age range indicating the number of animals 

at the minimum age.
Guidance to Industry: Preparing Supporting Summaries for Single-Tier Effectiveness Statements

September 1, 2020 Page 6 of 10

Challenge Description Include the challenge agent and time interval between the last 

product dose and challenge. If the challenge agent is a generally 

recognized strain (e.g., Singer strain of BVD1 or Rickard strain 

of FeLV), please indicate it.) 

• Bovine Virus Diarrhea Virus-state the type, subtype, and

strain.

• Infectious Bronchitis Virus-state the type.

• Infectious Bursal Disease Virus-state the type.

• Influenza Virus-state the subtype and strain. Designate

the strain according to accepted standards of influenza

virus nomenclature.

• Newcastle Disease Virus-state the strain.

• Porcine Circovirus-state the type and subtype.

• Rabies Virus-state the strain.

Enter “Not applicable” for safety studies.

Interval observed after 

challenge

Specify how long, and how frequently, animals were monitored 

for safety studies and after challenge for efficacy studies.

Results

***See the following section of this document for data 

formatting requirements.*** 

Efficacy: Focus on results that provided the primary basis for 

regulatory acceptance. Avoid myriad unremarkable secondary 

findings. 

Define any complex case definitions and indicate when the test 

was conducted according to a codified Standard Requirement. 

Explain scientific/medical terms in plain language. 

If multiple dose concentrations or different routes of 

administrations were tested, present only the data for the 

formulation/route that was approved for licensure. 

Safety: Account for all enrolled animals by adverse event 

observed. 

Presentation:

If a table or graphical presentation does not fit easily in the 

Results block of the ISS template, append additional pages to the 

template and refer the user to the added pages. If the data fit 

better on 8.5 x 11” pages in landscape view, it is permissible to 

rotate the data sideways on portrait-oriented pages. (Example 

ISS #9 contains rotated text.) Do not rotate individual pages 

within the Word document, however, as this creates problems 

during the CVB’s automated compilation of a Product 

Compilation Summary.
Guidance to Industry: Preparing Supporting Summaries for Single-Tier Effectiveness Statements

September 1, 2020 Page 7 of 10

If data were presented in tabular format in the study report, the 

same table may be copied/pasted into the ISS, provided there is 

adequate resolution to retain readability.