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Animal Drug and Feeds Performance Goals

The following performance goal table summarizes the performance goals, yearly targets and actual reported data for the Animal Drugs and Feeds Program.

Given the uncertainty of final FY 2007 appropriation levels at the time FDA developed the performance targets for the FY 2008 Congressional Justification, FDA has included FY 2007 targets at both the President's Budget and the Continuing Resolution funding levels.

1. Promote safe and effective animal drug availability ensuring public and animal health by meeting ADUFA performance goals. (14020)

• Context of Goal: At the FY 2007 Continuing Resolution level, FDA fails to meet the minimum appropriation level required in order to collect and spend user fees under ADUFA. Under this scenario, FDA would need to initiate plans to shut down the ADUFA program, resulting in significant personnel losses. Under the FY 2007 Continuing Resolution, we also anticipate unpredictable performance impacts on FY 2008, the fifth (and final year) under the current ADUFA legislation.

The personnel losses under this scenario would reverse previously achieved performance and management process improvements causing:

• the inability to achieve the enhanced and predictable ADUFA performance goals (resulting in significantly longer review times);
• an increase in the backlog of submissions;
• reduced capability to resolve new and emerging scientific issues, hold pre-submission meetings and consultations, and a halt to development of quality business and information technology systems and solutions; and,
• a threat to public due to increased use of unapproved and improperly labeled drugs and chemicals to treat animal diseases.

Under the President's budget submission(s), for FY 2007 and FY 2008 the goals and targets reflect performance measures consistent with the goals industry has agreed upon for user fees. The targets reflect one of the user fee goals and the Center's move toward completion of 90% of specified new animal drug submission reviews within statutorily mandated time frames over a five-year period under ADFUA. In FY 2007 and FY 2008, CVM will meet the trigger condition required to collect user fees.

The Animal Drugs and Feeds Program initiated a user fee program upon passage of the FY 2004 appropriation. The user fee program reflects the implementation of a five-year plan to improve the performance for animal drug review. ADUFA permits collection of application, product, establishment, and sponsor fees to enhance the animal drug review process. The benefits provided by the user fee program include: shorter review times; a more predictable and stable review process; and, an overall reduction in drug development time.

As mandated by the Federal Food, Drug and Cosmetic Act, a new animal drug may not be sold in interstate commerce unless it is the subject of an approved New Animal Drug Application (NADA). An approved NADA means the product is safe and effective for its intended use and that the methods, facilities and controls used for the manufacturing, processing and packaging of the drug are adequate to preserve its identity, strength, quality and purity.

When a new animal drug application is submitted, CVM evaluates the information contained or referenced in the application. A determination is made whether the application is approved or not approved. The sponsor receives a letter informing them either of the approval or describing the deficiencies in the application. The â?œdays to reviewâ? refers to the time it takes to review and take an action on the original submission, or if needed, on subsequent recycles. This is different from total approval time, which is the time it takes from the original receipt of the application until it is finally approved, which may take more than one review cycle. This includes the time we spend reviewing the application in each of the review cycles plus the time taken by the sponsor to respond to the issues raised in the not approved letter(s) and to resubmit the application for review.

FDA is encouraging sponsors to use the phased review process for new animal drug applications. An Investigational New Animal Drug (INAD) file or submission is established at the request of the sponsor to archive all sponsor submissions for a phased drug review, including: request for interstate shipment of an unapproved drug for study, protocols, technical sections, data sets, meeting requests, memos of conference, and other information. Phased review has removed a common bottleneck caused by the fact that a sponsor had to wait until all technical sections were reviewed before FDA would render an opinion on the sufficiency of an application. As a result, the technical section in the application that required the longest review could stymie progress on other sections. Under phased review, sponsors can coordinate submission of each technical section as the work for that section is completed. In addition, the direct review program, when linked with phased review, has resulted in significantly improved and more interactive communication between sponsor and reviewer, enabling a more efficient and logical review process.

• Performance: Based on the final performance update for FY 2005, FDA exceeded all ADUFA performance goal(s). FDA reviewed and acted on all four (4) original NADAs and reactivations of such applications received during FY 2005 within 270 days. Final performance numbers for FY 2006 will not be available until January 2008. However, as of September 30, 2006, the preliminary performance assessment for FY 2006 indicates FDA has exceeded the ADUFA goal(s). Additional information is forthcoming in the FY 2006 ADUFA Performance Report.

2. Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities. (14009)

• Context of Goal: Important features of the risk-based strategy for this goal will be reducing the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for greatest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. The Field notes that these goals were reported in previous years as inspection of a fixed percentage of the inventory of establishments. However, given the fluctuation in the inventory, the inspection resources available, and the risk-based prioritization approach that FDA is developing, FDA believes that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. ORA has reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better address and communicate to our stakeholders about animal drugs and feed safety risks.

One part of this goal includes inspections done by FDA directly, or through state contracts or partnership agreements, on manufacturers, repackers and relabelers of animal drugs, and manufacturers and growers requiring a Medicated Feed Mill License. The approximate statutory inspection inventory for this goal is 1,300 firms.

FDA developed a comprehensive public protection strategy of education, inspection and enforcement action. These activities will ensure compliance with the Bovine Spongiform Encephalopathy (BSE) feed regulations. Using an inventory of all known renderers and feed mills processing products containing prohibited material, FDA will continue to conduct annual inspections to determine compliance with the BSE feed rule. Inventories of these firms may vary from year to year based on changes at the firm such as consolidations, business closures, relocations, etc.

FDA and states under contract and partnership conduct over 8,000 BSE inspections each year. FDA will continue to update and improve the inventory of firms with information from the mandatory feed registration system from states and other sources. The current inventory of renderers and feed mills processing products containing prohibited materials is less than 500 and continues to decrease. The FY 2005 BSE funding increase supported increases in FDA BSE investigational staff; initiated improvements in BSE data collection through the Electronic State Access to FACTS (eSAF) database; funded cooperative agreements in eight states for BSE monitoring and control infrastructure improvements; enhanced state and federal information on the inventory of animal feed firms and firms handling prohibited materials; and strengthened state infrastructure to monitor and respond to feed contamination with prohibited materials.

• Performance: In FY 2006, FDA exceeded the registered animal drugs and feed establishments' goal of 618 by inspecting 699 registered establishments; and, FDA completed the inspection of all 516 firms known processing with prohibited materials (PM) as part of a concentrated effort to prevent an outbreak of BSE in the U.S. A total of 11 other firms known processing with PM during the previous inspection were found to be no longer processing with PM or out of business.

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