From: APHIS Veterinary Services <APHISVS@subscribers.usda.gov>
Date: Wed, Jul 23, 2014 at 6:44 AM
Subject: APHIS Administrator Shares Update on Center for Veterinary Biologics Business Process Improvements
To: iammejtm@gmail.com
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Dear Stakeholders:
As you all know, APHIS has made customer service a focus, looking closely at our business processes with an eye towards streamlining steps, improving timeliness, and reducing costs where possible to help ensure the health and profitability of your industries. In fact, one of our top 10 goals to accomplish over the next 3-4 years is to see the business improvements for several processes, including our Veterinary Services' (VS) veterinary biologics program, implemented.
VS' Center for Veterinary Biologics (CVB) assures that pure, safe, and effective veterinary biologics are available for the diagnosis, prevention, and treatment of animal diseases. In the past, long process times affected the veterinary biologics industry's ability to put new and innovative products on the market. CVB began looking at process improvement in 2011, with the goal of reducing its veterinary biologics licensing processes by 20 percent. CVB continued its process improvement efforts in 2012 and 2013 to focus on reducing the time it takes to review applications, making product labels easier to understand, as well as increasing customer service and transparency of their processes, all of which allow important new veterinary biologics to safely move to market faster.
Due to these efforts, biologics manufacturers can now submit product licensing requests and much of the supporting documentation electronically, an opportunity currently being utilized for approximately 80% of licensing submissions. CVB is also providing market release authorizations electronically now, instead of by mail.
CVB is still working through another process improvement project, making product labeling more consistent and easier to understand. We recently issued a proposed rule that would allow us to use a simpler labeling format that would better communicate product performance to the user. The current label format, which reflects any of four different levels of effectiveness, would be replaced with a single, uniform label format. We are also proposing to require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to APHIS in support of product licensing. We developed this proposed rule after meeting with the biologics manufacturers and discussing a concept paper.
APHIS remains committed to providing a high level of customer service to you, our stakeholders, and to safeguarding American agriculture. The improvements CVB is making are not the end. We will continue to look for opportunities to improve our business processes so that we can save time and resources.
Sincerely,
Kevin Shea APHIS Administrator
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Jeremy Tobias Matthews
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