The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced plans to streamline and improve several of the programmatic processes its customers use most, including the veterinary biologics licensing process. Last week, Agriculture Secretary Tom Vilsack highlighted improvements to a host of USDA programs and processes, including veterinary biologics licensing, being made to help farmers, ranchers and businesses continue to drive America’s productive agricultural economy.
“We heard from our customers that long review and licensing processes for veterinary biologics were impacting their ability to do business,” said Ed Avalos, undersecretary for marketing and regulatory programs. “After an ambitious review, we are making changes to improve our transparency, accountability and the predictability of our processes, while still carrying out our important oversight role. This change is part of our commitment to improving the customer experience by streamlining processes, accelerating delivery and using innovative technologies.”
APHIS identified numerous ways to save time throughout the review and licensing process, including:
- Allowing industry to provide a project development plan to identify the steps that must be completed to gain licensure;
Establishing agreements that document mutually agreed upon standards;
- Simplifying the product reference qualification/requalification process for older legacy products and extending the use of these references to 15 years;
- Standardizing the statistical data submissions by industry in support of licensing and other services;
Simplifying the conduct and review of studies that support the efficacy of veterinary biologics while maintaining the high quality of data review; and
- Streamlining the process that occurs once all of the materials necessary to recommend product licensure are submitted by industry.
APHIS expects these changes will reduce the overall time it takes to process a complete license application by about 100 days, a savings of 20 percent, with the potential for additional time savings as these changes are implemented. The new improvements will also enable APHIS to better track applications that are pending, especially those which have seen little to no activity over a protracted period of time.
“What’s important to us is that the changes we are undertaking will not only have a direct benefit for the biologics businesses, but also the livestock industry,” said Avalos. “Companies have estimated that a one-year delay costs them $5 to $10 million. Our new process will create valuable savings and help drive growth.”
The improvements to APHIS’ veterinary biologics licensing and review process are part of Secretary Vilsack’s effort to transform USDA into a high-performing organization that focuses on its customers. APHIS process improvements are part of the USDA Customer Service Plan which identifies key actions and initiatives aimed at improving the customer experience, modernizing and streamlining processes, reducing costs, accelerating delivery and using innovative technology to advance customer service.