Docket No. APHIS-2011-0049

Concept Paper: Single Tier Label Claim

Purpose. To eliminate confusion in interpreting our current four tiered label claim system and 

provide veterinary practitioners and other users of veterinary biologics with the information 

needed to reach their individual decisions regarding the efficacy of such products, the Center for 

Veterinary Biologics (CVB) is considering changes to our procedures for approving indications 

for use statements in veterinary biologics labeling. In addition to providing relevant information 

concerning the performance of veterinary biologics in efficacy studies, the initiative also would

allow better utilization of the resources of both government (CVB) and the regulated industry,

and may enable veterinary biological products to reach the marketplace in a timelier manner. 

Background. Part 112 of the Virus-Serum-Toxin Act regulations (9CFR, part 112) describe 

labeling requirements for veterinary biologicals. Section 112.2 (a) (5) states that vaccination 

schedules, warnings, cautions, etc. must be included on container labels. Veterinary Services 

Memorandum (VSM) 800.202 (dated June 12, 2002) provides guidance concerning indications 

statements that are allowable in veterinary biologics labeling provided, that efficacy studies are 

performed in accordance with any one of four procedures outlined therein. Efficacy is defined in 

the regulations as the capacity of the product to effect the result for which it is offered when used 

as recommended in labeling. Current label claims for efficacy as described in VSM 800.202 

consist of four efficacy levels and vary widely from minimal efficacy to full protection. 

Veterinary biologics manufacturers and veterinary practitioners as represented by the American 

Veterinary Medical Association have expressed concern that the current indications statements

are confusing and do not provide meaningful information regarding the performance of the 

product to the end-user. 

Concept. The proposed concept has two components. The first component proposes to change

the current four levels of label claims to a single claim that will apply to all products. The 

second component is the development of a website (location to be determined) where end-users 

may go to review a summary of the efficacy data on which we based our decision to issue the 

product license. This website would allow the end-user to compare efficacy data for similar 

products. The proposed concept will apply immediately to products that are in the early stages 

of licensure. The timeframe for applying the 1-tier claim concept to legacy products is open for 

discussion at the Public Meeting. 

For the label claim component, we propose a simple label claim similar to: “This product has 

been shown to be effective for the vaccination of healthy dogs 12 weeks of age or older against 

canine distemper cause by (due to) Canine Distemper Virus.” In the example, the current four 

levels of efficacy claims have been replaced with a single word: effective. In addition, labeling 

would include a statement referring users to either the product insert and/or a website (location to 

be determined should they desire to review a summary of the efficacy data. 

The efficacy data summary will be provided in tabular format for ease of comparison between 

and among products and will include relevant information regarding the design of the study (i.e., 

number and age of animals at first vaccination; timing and route of vaccination; challenge 
Docket No. APHIS-2011-0049

organism (strain identified as either “CVB strain” or “proprietary strain”), concentration, and 

route of exposure; etc) and a simplified presentation of the data generated from the study. Data 

will consist of the number of control and challenged animals exhibiting relevant clinical signs 

that were used by the CVB to establish efficacy. Interpretation of the data summary is left to the 

end-user of the product. 

Example of an Efficacy Licensing Summary

Establishment Name/Number ABC/Est. No. 000

True Name/Trade Name Mycoplasma Hyopneumoniae Bacterin/Dessuegi-1® and Erysipelothrix 

Rhusiopathiae-Mycoplasma Hyopneumoniae Bacterin/Dessuegi-2®

Number of doses , Route & 

Timing of Administration 

Two doses of 2mL each, intramuscular, each administered 14 days 

apart

Study Design

Number of animals/group; 

Type of animals and age at first 

vaccination/treatment

Twenty-four 2-14 day old pigs derived from gilts/sows with no history 

of vaccination or exposure to Mycoplasma hyopneumoniae 

Challenge Data

Challenge organism & 

dose/Method & Timing of 

Challenge

CVB strain or proprietary strain of M. hyopneumoniae 10mL 

(1.1x105CFU/mL) administered intratracheally 28 days after the 

second vaccination

Efficacy Outcome/Results No. Animals with Presence of Clinical Signs After Challenge

Clinical Sign Controls (24) Vaccinates (24)

Dry Cough 19 2

Respiratory Distress 14 1

Lung Lesions 24 6

Enlarged Lymph Nodes 2 0

Death 4 0