Docket No. APHIS

- 2011

- 0049



### Concept Paper: Single Tier Label Claim

Purpose

. To eliminate confusion in interpreting our current four tier ed label claim system and provide veterinary practitioners and other users of veterinary biologics with the information needed to reach their individual decisions regarding the eff icacy 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, t he initiative also would allow better utilization of the resources of both government (CVB) and the regulated industry

, and may enable v eterinary biological products to reach the marketplace in a timelier manner.
Background

. Part 112 of the Virus

- Serum

- Toxin Act regul ations (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 b iologics labeling provided, that efficacy studies are performed in accordance with any one of four procedures outlined therein

. Efficacy is defined in
t he 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 e nd

- use r

. Concept

. The proposed concept has two components. The first component propose s to chang e 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 s ummary of the efficacy data on which we based our decision to issue the product license

. Th is website would allow the end

- user to compar e efficacy data for similar products. The proposed conc ept 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 , t he current four levels of efficacy claims have been replaced with a single word: effective . In addition, labeling would include a statement refer ring user s 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 compari son between and among products and will include relevant information regarding the design of the study (i.e.,

n umber and age of animals at first vaccination; timing and route of vaccination; challengeDocket 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 gene rated 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.



### E xample of an E fficacy 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 M ycoplasma hyo pneumoniae

Challenge Data

Challenge organism &
dose /Method & Timing of

Challenge CVB strain or proprietary strain of M. hyopneumoniae 10mL

(1.1x10 5 CFU/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

D eath 4 0