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ARS Home » Research » Research Project #439135

Research Project: Veterinary Countermeasures Biologics Development Based on USDA Center for Veterinary Biologics Regulations for Successful Licensure of New Products

Location: Research Programs

Project Number: 3022-32000-017-006-A
Project Type: Cooperative Agreement

Start Date: Sep 1, 2020
End Date: Jun 30, 2022

Objective:
The USDA, Agricultural Research Service (ARS) National Program on Animal Health strives to be an international leader in animal health by working to deliver effective solutions to prevent and control animal diseases that impact agriculture and public health. ARS projects involve research to develop vaccines and diagnostics. ARS scientists and their collaborator universities and other institutions would benefit from a better understand of the requirements for licensure of vaccines and diagnostics as they develop and design research programs. This will ensure a successful transfer of technology developed in research laboratories to improve animal health and production. The IICAB works with the veterinary biologics industry, government regulatory and research agencies, universities, veterinarians, and producers in an effort to improve the availability and use of biologics for animals worldwide. The CVB is responsible for the regulation of the production, testing and distribution of veterinary biologics in the U.S. CVB administers a program of licensing, testing and inspection to assure that products distributed in the U.S. for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective and not worthless, dangerous, contaminated or harmful.

Approach:
The IICAB proposes to work with the CVB to create an online course on the USDA licensing program and related issues to improve the transfer of technology developed in ARS research laboratories. IICAB will modify a series of lectures given by CVB staff at the 2019 Veterinary Biologics Training Program and place recorded lectures on an online learning platform. IICAB will also record the VBTP anticipated to be offered in May 2021 and modify the recorded lectures to produce an updated course to be offered in summer of 2021. IICAB will work with ARS National Program staff to inform ARS scientists about the course and encourage its use, will sign approved users up for the course, track users through the course and provide user support.