Animal-use vaccines will likely become licensed more quickly as a result of changes in Department of Agriculture processes, department officials said.
The USDA Animal and Plant Health Inspection Service also announced that the agency plans to reduce the amount of time taken to assess risks and implement new rules. Dr. John R. Clifford, deputy administrator for APHIS Veterinary Services, said in a conference call Nov. 14, 2011, that while APHIS is a regulatory agency with oversight accountability, it should and can put "customers" first and deliver services efficiently, effectively, cheaply, and quickly.
"So by significantly shortening the timelines of those processes that APHIS customers use most, APHIS will be providing them with valuable savings, something much needed as companies have been increasingly challenged by today's economy," Dr. Clifford said.
The conference call followed publication of a letter to stakeholders from APHIS Administrator Gregory L. Parham, who said the agency is committing to changing long-standing processes in response to complaints about slow license and permit approval processes, burdensome rule-making procedures, and confusing applications of some regulations.
"Our work was based on the premise that APHIS can be both a strong regulatory agency and business-minded at the same time, while increasing our transparency, accountability, and the predictability of our processes," the letter states.
The letter indicates the agency, in considering possible changes, focused on reducing the time needed to license animal-use biologics, improving tribal consultation, evaluating the regulatory status of genetically engineered organisms, improving efficiency of the enforcement process for regulatory violations, improving the efficiency of the risk assessment and rule-making processes for imported plant and animal products, reducing complaints and calls for investigations of employee misconduct, and improving efficiency of complaint investigations.
Dr. Richard E. Hill, director of the APHIS Center for Veterinary Biologics, said the proposed changes could reduce the average time taken to approve licenses for veterinary biologics by more than 20 percent, or about 100 days. Toward that goal, APHIS actions would encourage submission of statistical data in a standardized format; modify rules on labeling from a system of tiered claims to a single, standardized claim; encourage companies to produce development plans that detail expectations and strategies; and provide critical path agreements to show what is needed to gain a license.
"Our work was based on the premise that APHIS can be both a strong regulatory
agency and business-minded at the same time, while increasing our
transparency, accountability, and the predictability of our processes."
Dr. Gregory L. Parham, APHIS administrator, in an open letter from the agency
Dr. Hill said veterinarians, animal owners, and state and federal agencies that use veterinary biologics "will all benefit from earlier access to the newest product advances." Biologics producers also could invest more money toward developing vaccines for emerging needs, more quickly market products, and save millions of dollars in development cycles.
Stephen O'Neill, chief of regulatory analysis and development for APHIS, said the agency and trading partners both saw the need to reduce the time taken for risk assessments and rule making. The agency was working to reduce process-related delays, provide standard operating procedures, and set clear expectations for timeliness of agency work. Changes planned so far could reduce by one-quarter or one-fifth the time needed for risk assessments, O'Neill said.
About 1,060 days typically pass between when the APHIS conducts a risk assessment and publishes an animal health rule, O'Neill said. But the proposed business improvements could reduce that average to 770 days. Evaluating and upgrading a country's status connected with a particular disease currently takes about 885 days, but that average could be decreased to about 660.
O'Neill said that the internal process changes are not going through the regulatory rule-making process. The agency has not set a timeline for implementation.