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Animal Drugs and Feeds Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

 Long Term Objective:  Advance Animal Drug Safety and Effectiveness

 

Measure

FY

Target

Result

242201:  Review adverse experience reports to detect animal product hazards early. (Output)

2012

55%

January 2013

2011

22%

January 2012

2010

50%

22%

(Target Not Met)

2009

N/A

34%

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

243201: Complete review and action on original New Animal Drug Applications (NADAs) and reactivations of such applications received during the fiscal year. (Output)

2012

90% w/in 180 days

January 2014

2011

90% w/in 180 days

January 2013

2010

90% w/in 180 days

January 2012

2009

90% w/in 180 days

100% of 5 w/in 180 days

 (Target Exceeded)

2008

90% w/in 180 days

100% of 4 w/in 180 days
(Target Exceeded)

2007

90% w/in 200 days

100% of 7 w/in 200 days

(Target Exceeded)

243202: Complete review and action on Non-administrative original Abbreviated New Animal Drug Applications (ANADAs) and reactivations of such applications received during the fiscal year. (Output)

2012

90% w/in 380 days

January 2015

2011

90% w/in 500 days

January 2014

2010

90% w/in 680 days

January 2013

2009

90% w/in 700 days

January 2012

2008

N/A

N/A

2007

N/A

N/A

 

Measure

Data Source

Data Validation

242201

Adverse Drug Experiences (ADE) database

CVM utilizes and maintains an Adverse Drug Experiences (ADE) database to provide an early warning or signaling system to the Center for adverse effects not detected during pre-market testing of FDA-approved animal drugs and for monitoring the performance of drugs not approved for use in animals. 

243201

243202

Submission Tracking and Reporting System (STARS).

STARS tracks submissions, reflects the Center’s target submission processing times and monitors submissions during the developmental or investigational stages and the resulting application for marketing of the product.

 


 

Measure

FY

Target

Result

244202: Number of domestic and foreign high risk animal drug and feed inspections.   (Output)

2012

250

December, 2012

2011

250

December, 2011

2010

250

279

(Target Exceeded)

2009

233

262

(Target Exceeded)

2008

233

244
(Target Exceeded)

244203: Number of targeted prohibited material BSE inspections.  (Output)

2012

500

December, 2012

2011

490

December, 2011

2010

490

567

(Target Met)

2009

490

526

(Target Exceeded)

2008

490

555
(Target Exceeded)

2007

490

523
(Target Exceeded)

244204: Complete review and action on warning letters received within 15 working days to better safeguard our food supply by alerting the firms to identified deviations in order to become compliant.  (Output)

2012

50% w/in 15 working days

January 2013

2011

50% w/in 15 working days

January 2012

2010

80% w/in 15 working days

25% w/in 15 working days

(Target Not Met)

2009

N/A

38% w/in 15 working days

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

244301: The total number of collaborating laboratories that will provide coordinated response to high priority chemical and microbial animal feed contamination events. (Outcome) 

2012

11

January 2013

2011

9

January 2012

2010

2

9

(Target Exceeded)

2009

N/A

0

(Historical Actual)

2008

N/A

N/A

2007

N/A

N/A

         

 


 


Measure

Data Source

Data Validation

244202
244203

 

 

 

 

 

 

 

 

 

 

Field Data Systems

 

 

 

 

 

 

 

 

 

 

 

ORA uses two main information technology systems to track and verify field performance goal activities: the Field Accomplishments and Compliance Tracking System (FACTS) and the Operational and Administrative System Import Support (OASIS). FACTS includes data on the number of inspections; field exams; sample collections; laboratory analyses; and, the time spent on each. OASIS, which is coordinated with U.S. Customs and Border Protection, provides data on what FDA regulated products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. FDA is currently developing the Mission Accomplishment and Regulatory Compliance Services (MARCS) system. MARCS will incorporate the capabilities of these two field legacy systems, FACTS and OASIS, and will also include additional functionality.

244204

Compliance Management System (CMS)

An electronic case submission system used to process all violation letters.

244301

CVM

Data validated by the appropriate CVM program office.

 

1.      Review adverse experience reports to detect animal product hazards early.   (242201)

 

Context:  Protecting the public health includes monitoring marketed animal drugs, pet food, and veterinary devices to assure their safety and effectiveness.  FDA relies on information from adverse event reporting to ensure the safety of animal drugs, pet food, and devices.  All information and insight learned from the adverse event program is used to proactively identify drug safety signals and effectiveness issues of concern.  For example, pet owners may be exposed to potent hormones, cancer drugs and other potentially toxic drugs.  Inappropriate use of animal drugs in food producing species may also result in drug residues involving milk and meat.  Also, pets receiving multiple medications may become ill from unknown drug interactions (they are not on the label) when these products are prescribed by their veterinarians.  FDA works with the drug manufacturers, so this information can then be expeditiously communicated to veterinarians and consumers to prevent and mitigate risks associated with the use of these products.  More timely and effective communication of adverse event issues to practitioners and the public will help prevent harm to animals and humans and may reduce product liability issues for drug manufacturers as well.  Also, this adverse event program data and information benefits the FDA pre-approval process as it identifies safety and effectiveness issues that should be addressed as similar or related products are being developed by drug manufacturers

 

Performance:  FY 2009 baseline data reflects the Center for Veterinary Medicine (CVM) reviewed 34% of the AERs received.  CVM reviewed 22% of the AERs received in FY 2010.   Performance was impacted by insufficient program staffing, software complications and information technology (IT) deficiencies associated with the new electronic submissions system.  CVM anticipates FY 2010 level of performance to continue into FY 2011.  Review performance of AERs is expected to rise to 55% in FY 2012 due to the increase request, as well as IT support improvements.

 

2.      Complete review and action on original NADAs and reactivations of such applications received during the fiscal year.   (243201)

 

Context:  The FY 2009, FY 2010, FY 2011 and FY 2012 goal and targets reflect the reauthorization of ADUFA and continued achievement of statutory review timeframe(s) over a five-year period (FY 2009-FY 2013).  The goal and targets reflect one of the ADUFA user fee goals and CVM’s ability to maintain FY 2008 review time frames for specified new animal drug application reviews. 

 

Performance:  Based on the final performance update for FY 2008, FDA exceeded all ADUFA performance goals.  FDA reviewed and acted on all four original NADAs and reactivations of such applications received during FY 2008 within 180 days.  As of September 30, 2010, the final performance assessment of FY 2009 data indicates FDA exceeded all ADUFA goal(s), including submissions under the end-review amendment (ERA) process. For FY 2010, FY 2011, and FY 2012, CVM plans to review and act on all original NADAs and reactivations of such applications received within 180 days.

 

3.      Complete review and action on Non-administrative original ANADAs and reactivations of such applications received during the fiscal year.  (243202)

 

Context:  This new measure reflects the FY 2008 authorization of the new Animal Generic Drug User Fee Act (AGDUFA).  The FY 2009, FY 2010, FY 2011, and FY 2012 goal and targets reflect one of the AGDUFA user fee goals to complete the review of 90% of specified abbreviated applications for the approval of generic new animal drugs within incrementally decreasing time frames over a five-year period (FY 2009-FY 2013).  

 

Performance:  AGDUFA is a new performance goal and target as of FY 2009.  For FY 2009, FY 2010, FY 2011, and FY 2012, CVM plans to review and act on all non-administrative original ANADAs and reactivations of such applications received within 700 days, 680 days, 500 days, and 380 days, respectively.

 

4.      Number of domestic and foreign high risk animal drug and feed inspections.  (244202)

 

Context:  Important features of the risk-based strategy for this revised goal are to reduce the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for risk.  This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified.  In FY 2008, this revised goal focused on pre-market approval inspections and implementing risk-based current Good Manufacturing Practices (cGMP) inspection plans for animal drug and feed manufacturing facilities that utilized risk modeling to identify the highest risk firms to be inspected.  The FY 2008 target was maintained in FY 2009 because this was a new, risk-based goal for which FDA had no historical experience, and was unsure how the new site-selection methodology would evolve.  In FY 2010, the target was slightly increased as a result of the FY 2009 Appropriation while evaluation of the new methodology continues.  In FY 2012, the target is being maintained at the FY 2011 level.

 

Performance: In FY 2010, FDA exceeded this inspection goal of 250 by inspecting 279 high risk animal drug and feed establishments.

 

5.      Number of targeted prohibited material BSE inspections   (244203)

 

Context:  FDA developed a comprehensive public protection strategy of education, inspection and enforcement action to 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.  In FY 2012, FDA will continue to conduct inspections of 100% of the firms known to be processing with prohibited materials.

 

Performance: In FY 2010, FDA completed the inspection of all 567 firms known to be processing with prohibited materials as part of a concentrated effort to prevent an outbreak of BSE in the U.S.

 

6.      Complete review and action on warning letters received within 15 working days to better safeguard our food supply by alerting firms to identified deviations in order to become compliant.   (244204)

 

Context:  Issuing warning letters is the agency's principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (the Act) for violations of regulatory significance that may lead to enforcement action if not promptly and adequately corrected. FDA sends warning letters to individuals or firms, advising them of specific noted violations and requesting a written response as to the steps which will be taken to correct the violation. 

 

Performance:  As part of the FDA Enhanced Enforcement Strategy, FDA will:  1) streamline the warning letter process by only having the letter reviewed by the relevant offices; 2) prioritize follow-up on warning letters and other enforcement actions quickly to assess and follow-up on corrective action taken by industry after a warning letter is issued or a major product recall occurs; and 3) determine a firm has fully corrected violations raised in a warning letter, issue an official “close-out” notice and post this information on the FDA website, motivating manufacturers to take corrective actions promptly. FY 2009 baseline data reflects CVM completed review and action on 38% of the warning letters received within 15 working days. In FY 2010, CVM completed 25% of the warning letters received within 15 working days.   In FY 2010, staff were deferred from work on the increasing load of warning letters to work on the increased number of injunctions, which have a higher priority.  In addition, staff time had to be shared with the development and implementation of new regulations and training related to the Food and Drug Administration Amendments Act (FDAAA) and the Food Safety Modernization Act (FSMA).  CVM anticipates the FY 2010 workload will continue into FY 2011 and FY 2012 but plans to have complete review and action on 50% of warning letters within 15 days of Center receipt.

 

7.      The total number of collaborating laboratories that will provide coordinated response to high priority chemical and microbial animal feed contamination events.   (244301)

 

Context:  The lack of coordination between federal and state veterinary diagnostic laboratories to respond to high priority chemical and microbial feed contamination events by examining animal tissues for infectious agents/toxins, puts animals at risk to both inadvertent and intentional introduction of contaminants.  FDA will improve emergency response by developing a network of state and federal laboratories that integrate resources and expertise for timely and accurate reporting, identification, and analysis of animal feed contamination events through examination of animal tissues for infectious agents, toxins, and other causes of disease.  The network will enhance the ability to conduct root cause analysis and develop the data, information, and protective measures needed to help prevent future outbreaks.

 

Performance:  The network will coordinate the facilities, equipment and professional expertise of U.S. and federal veterinary diagnostic laboratories to provide the means for quick identification of reports of animal injury associated with animal feed contamination, and protocols for immediate diagnostic reporting to FDA.  In FY 2010, CVM collaborated with ORA and USDA to fund 9 diagnostic laboratories.  In FY 2011, CVM is implementing a grant review process to support 9 laboratories in FY 2011 and 11 laboratories in FY 2012.  


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