Regulatory Brief

 Electronic Freedom of Information Act Involving Veterinary Biological Products


Formal title: Veterinary Services Memorandum Draft Number 336: Electronic Freedom of Information Act Involving Veterinary Biological Products

The United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB) is providing guidelines concerning the CVB's implementation of the Electronic Freedom of Information Act (EFOIA) as it applies to materials submitted to the CVB by manufacturers for new veterinary biological products.

Brief Description:

Since its enactment in 1966, the Freedom of Information Act has been amended seven times. With each amendment, the original Act has been broadened to encompass additional information deemed necessary to the public, including the oversight of the federal government. Specifically, federal agencies are required to automatically make certain categories of information available to the public in electronic form. As a result, the CVB will prepare and publish electronic summaries for all efficacy and safety studies used to support licenses, permits, and product revisions for public access via the agency's website.

AVMA Response:

The AVMA is highly supportive of draft no. 336 to publish electronic summaries for all efficacy and safety studies used to support licenses, permits, and product revisions for public access via the agency's website. The AVMA believes there is a need for biologic labels to communicate an appropriate expectation of product performance to users of the products. The AVMA is pleased with the improved disclosure of information generated to support product licensure and commends the USDA APHIS VS CVB for seeing this important initiative to fruition. The EFOIA initiative is one component of AVMA's larger labeling initiative.

Background Documents:

View AVMA response to USDA (PDF)

View APHIS Veterinary Services Memorandum Draft No. 336

Status:

AVMA responded on April 25, 2008.