The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service today issued a notice to inform producers and users of veterinary biological products of a public meeting from 9 a.m. to 3 p.m., June 16 at the National Centers for Animal Health in Ames, Iowa.
Attendees will discuss a draft guideline concerning the effectiveness indications statements in veterinary biologics labeling.
The USDA is making the concept paper available for review and comment and will consider all comments received on or before July 25.
The regulations issued pursuant to the act are intended to ensure that veterinary biological products are pure, safe, potent and effective when used according to label instructions, the USDA states. The regulations prescribe requirements for packaging and labeling veterinary biologics and ensure that labeling provides adequate information concerning the expected effectiveness and safety of the product.
Current APHIS guidelines provide examples of statements that may be used in labeling to describe the indications for use of a product, provided that the product has demonstrated a specified level of performance in an efficacy study that was the basis for issuance of the product license.
Submit comments and view the concept paper through the Federal eRulemaking Portal.