Regulatory Brief

 Biologic Labeling


Formal title: Docket Number [APHIS-2011-0049] Effectiveness Indications Statements in Veterinary Biologics Labeling; Notice of Public Meeting and Request for Comments

The U.S. Department of Agriculture (USDA) Animal Plant Health Inspection Service (APHIS) has announced its notice of public meeting and request for comments regarding effectiveness indications statements in veterinary biologics.

Brief Description:

The USDA APHIS issued this notice to inform producers and users of veterinary biological products, as well as other interested individuals, that a public meeting will be held to discuss a draft guideline (concept paper) concerning effectiveness indications statements in veterinary biologics labeling. The concept paper will be available for review and comment.

AVMA Response:

The AVMA is pleased with the improved disclosure of information generated to support product licensure and commends the USDA, APHIS, Veterinary Services (VS) Center for Veterinary Biologics (CVB) for seeing this important initiative to fruition. The AVMA also appreciates the opportunity to have provided verbal comments at the USDA's June 16, 2011 public meeting regarding the policy guidance/concept paper USDA recently published in the Federal Register on May 24, 2011. The AVMA is encouraged by the CVB's work to modify vaccine labels to ensure that only science-based, clinically relevant information is made available. Veterinary vaccine labeling is a long-standing interest for the AVMA and we recognize and commend the CVB on the substantial progress made by the CVB with regard to vaccine labels, especially in the face of continued budgetary constraints.

The AVMA wholeheartedly supports the CVB's proposed concept to change the current four levels of label claims to a single claim to be used for all products. It is important that the claim, in combination with supporting efficacy and safety data, provides a realistic expectation regarding product performance.

The AVMA stands ready to assist the CVB in its implementation of substantial changes to vaccine labels to make them more informative and understandable for end-users. The AVMA supports CVB's willingness to develop guidance documents explaining changes to vaccine labels, and we offer our assistance as the CVB develops such guidance.

Background Documents:

The AVMA responded on July 25, 2011 (PDF)

View Federal Register document (PDF)