Regulatory Brief

 Studies to Support Label Claims of Duration of Immunity


Formal title: Center for Veterinary Biologics Notice Draft No. 327: Studies to Support Label Claims of Duration of Immunity

The Center for Veterinary Biologics (CVB) announced its notice governing studies to support label claims of duration of immunity.

Brief Description:

The CVB's intent is to provide clarification to licensees, permittees, and applicants of current Center for Veterinary Biologics (CVB) policy regarding studies to support duration of immunity (DOI) label claims for veterinary biologics. Studies conducted to support DOI label claims should be designed to ensure claims which are not false and misleading, as per Title 9, Code of Federal Regulations, Part 112.11(b). Protocols for DOI studies should include the age of animal to be vaccinated, the formulation of the product to be used, and when the animals will be challenged.

AVMA Response:

The AVMA is pleased with the improved disclosure of information generated to support product licensure. The AVMA commends the CVB for providing its recommendations to the relevant stakeholders, regarding the means by which DOI should be determined, and the way in which label claims showing DOI should be designed.

The AVMA urges that science-based labels should provide a summary of data to explain what is known about the DOI for that product. The AVMA commends the CVB for its recognition for the need for specific study protocols to be utilized in order to procure adequate scientific support for DOI claims.

Background Documents:

View AVMA's response to USDA (PDF)

View USDA Document

Status:

AVMA responded on October 27, 2008