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Office of Regulatory Affairs Performance Detail FY 2012 OPA

Table of Contents FY 2012 OPA

Long Term Objective: Advance Food Safety and Nutrition
 
Measure
FY
Target
Result
214201: Number of prior notice import security reviews.  (Output)
2012
80,000
December, 2012
2011
80,000
December, 2011
2010
80,000
81,618
(Target Exceeded)
2009
80,000
81,157
(Target Exceeded)
2008
80,000
80,543
(Target Exceeded)
2007
60,000
84,088
(Target Exceeded)
214202: Number of import food field exams. (Output)
2012
160,000
December, 2012
2011
160,000
December, 2011
2010
140,000
170,392
(Target Exceeded)
2009
120,000
138,916
(Target Exceeded)
2008
85,000
100,718
(Target Exceeded)
2007
71,000
94,743
(Target Exceeded)
214203: Number of Filer Evaluations.  (Output)
2012
1,000
December, 2012
2011
1,000
December, 2011
2010
1,000
1,277
(Target Exceeded)
2009
1,000
1,208
(Target Exceeded)
2008
1,000
1,356
(Target Exceeded)
2007
1,000
1,355
(Target Exceeded)
214204: Number of examinations of FDA refused entries.  (Output)
2012
7,000
December, 2012
2011
7,000
December, 2011
2010
7,000
8,658
(Target Exceeded)
2009
5,000
7,201
(Target Exceeded)
2008
4,000
5,926
(Target Exceeded)
2007
3,000
5,510
(Target Exceeded)
214205: Number of high risk food inspections.  (Output)
2012
8,850
December, 2012
2011
7,800
December, 2011
2010
6,750
6,926
(Target Exceeded)
2009
6,100
6,182
(Target Exceeded)
2008
5,700
6,230
(Target Exceeded)
2007
5,625
6,421
(Target Exceeded)
214303: Convert data from new eLEXNET participating laboratories via automated exchange or convert data from existing manual data streams to automated data exchange.  (Outcome)
2012
5 data exchange additions/conversions
December, 2012
2011
5 data exchange additions/conversions
December, 2011
2010
5 data exchange additions/conversions
5 data entry labs
(Target Met)
2009
5 data exchange additions/conversions
5 data entry labs
(Target Met)
2008
5 data entry labs
11 data entry labs
(Target Exceeded)
214206: Maintain accreditation for ORA labs. (Outcome)
2012
13 labs
December, 2012
2011
13 labs
December, 2011
2010
13 labs
13 labs
(Target Met)
2009
13 labs
13 labs
(Target Met)
2008
13 labs
13 labs
(Target Met)
2007
13 labs
13 labs
(Target Met)
214305: Increase laboratory surge capacity in the event of terrorist attack on the food supply. (Radiological and chemical samples/week). (Outcome)
2012
2,500 rad & 2,100 chem
December, 2012
2011
2,500 rad & 2,100 chem
December, 2011
2010
2,500 rad & 2,100 chem
2,500 rad & 2,100 chem
(Target Met)
2009
2,500 rad & 1,650 chem
2,500 rad & 1,650 chem
(Target Met)
2008
2,500 rad & 1,200 chem
2,500 rad & 1,200 chem
(Target Met)
2007
1,000 rad & 1,200 chem
1,000 rad & 1,200 chem
(Target Met)
 
Long Term Objective: Advance Human Drug Safety and Effectiveness
 
Measure
FY
Target
Result
224201: Number of foreign and domestic high-risk human drug inspections.  (Output)
2012
750
December, 2012
2011
750
December, 2011
2010
700
705
(Target Exceeded)
2009
600
687
(Target Exceeded)
2008
500
534
(Target Exceeded)
2007
500
583
(Target Exceeded)
 
Long Term Objective: Advance Biologics Safety and Effectiveness
 
Measure
FY
Target
Result
234202: Number of registered domestic blood bank and biologics manufacturing inspections.  (Output)
2012
1,000
December, 2012
2011
1,000
December, 2011
2010
1,000
1,073
(Target Exceeded)
2009
870
1,001
(Target Exceeded)
2008
870
1,014
(Target Exceeded)
234203: Number of human tissue establishment inspections.  (Output)
2012
533
December, 2012
2011
533
December, 2011
2010
518
564
(Target Exceeded)
2009
380
434
(Target Exceeded)
2008
325
383
(Target Exceeded)
2007
325
427
(Target Exceeded)
 
Long Term Objective: Advance Animal Drug Safety and Effectiveness
 
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)
 
Long Term Objective: Advance Medical Device Safety and Effectiveness
 
Measure
FY
Target
Result
253201: Number of Medical Device Bioresearch Monitoring (BIMO) inspections. (Output)
2012
300
December, 2012
2011
300
December, 2011
2010
300
392
(Target Exceeded)
2009
300
305
(Target Exceeded)
2008
300
301
(Target Exceeded)
2007
295
323
(Target Exceeded)
254201: Number of domestic and foreign Class II and Class III device inspections.  (Output)
2012
1,515
December, 2012
2011
1,445
December, 2011
2010
1,365
1,659
(Target Exceeded)
2009
1,340
1,471
(Target Exceeded)
2008
1,270
1,431
(Target Exceeded)
2007
1,195
1,468
(Target Exceeded)
 
Measure
Data Source
Data Validation
253201
CDRH Premarket Tracking System and Receipt Cohorts and Field Data Systems.
To help ensure Agency consistency in tracking and reporting Premarket activities, CDRH utilizes the Premarket Tracking System, which contains various types of data taken directly from the Premarket submissions. FDA employs certain conventions for monitoring and reporting performance; among these are groupings of Premarket submissions into decision and receipt cohorts. Decision cohorts are groupings of submissions upon which a decision was made within a specified time frame, while receipt cohorts are groupings of submissions that were received within a specified time frame. The Premarket performance goals are based on receipt cohorts. Final data for receipt cohorts are usually not available at the end of the submission year. Because the review of an application received on the last day of the submission year, e.g., a PMA with 180 day time frame, may not be completed for at least 6 months or longer, final data for the submission or goal year may not be available for up to a year or more after the end of the goal year.
 
 
Measure
Data Source
Data Validation
214201
214202
214203
214204
214205
214303
224201
234202
234202
244202
244203
254201
214206
214305
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 and include additional functionality.
 
1.      Number of prior notice import security reviews.  (214201)
 
Context:   FDA’s Prior Notice Center (PNC) was established in response to regulations promulgated in conjunction with the Public Health Security and Bioterrorism Preparedness Act of 2002 (BTA). Its mission is to identify imported food and feed products that may be intentionally contaminated with biological, chemical, or radiological agents, and/or to identify those that may pose a significant health risk to the American public and prevent them from entering into the U.S. food supply. FDA will continue to focus much of its PNC resources on intensive prior notice security reviews of imported food/feed shipments that pose the highest potential bioterrorism risks to the U.S. consumer. Every (100%) prior notice is electronically screened and targeted and all those identified as high risk receive an intensive security review. The total number of intensive prior notice security reviews conducted by the PNC is impacted by current intelligence factors, targeting priorities, and the number of high risk shipments being imported. Therefore, this total may increase or decrease in future years. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance:  During FY 2010, FDA received 10,039,557 prior notice submissions on which the PNC conducted 81,681 intensive prior notice security reviews of  import security reviews(exceeding the performance target of 80,000 reviews) to identify and intercept potentially contaminated food and animal food/feed products before they entered the U.S. A total of1,340 shipments were the subject of PNC compliance actions for prior notice or food facility registration violations, which was more than 1.5 times the total number of PN related actions from the previous fiscal year.  The PNC operations actively strengthen the U.S. food supply and provide early food security/defense driven targeting and risk assessments to detect food shipments that pose or may pose a potential terrorist threat.  In addition, the PNC responded to more than21,000 phone and e-mail inquiries, and conducted over826 informed compliance calls to the import trade in order to facilitate better compliance with the submission of accurate, timely prior notice information.
 
2.      Number of import food field exams on products with suspect histories. (214202)
 
Context:   The volume of imported food shipments has been rising steadily in recent years and this trend is likely to continue. FDA reviewed approximately 9.8 million line entries of imported food out of an estimated 20.0 million lines of FDA regulated products in FY 2009.  In FY 2010, FDA expects approximately 10.1 million line entries of imported food within a total of more than 23.2 million lines of FDA regulated entries. To manage this ever-increasing volume of imports, FDA uses risk management strategies to achieve the greatest food protection with available resources. While the percentage of imports physically examined may decline as imports continue their explosive growth, the exams that ORA conducts are more targeted and more effective than ever before. ORA continues to think that the best approach to improve the safety and security of food import lines is to devote resources to expand targeting and follow through on potentially high-risk import entries rather than simply increasing the percentage of food import lines given a field exam. In FY 2009 through FY 2011 FDA increased the target by 20,000 exams each year. In FY 2012, the target is being maintained at the FY 2011 level of 160,000 field exams.
 
Performance: In FY 2010, FDA exceeded the target of 140,000 by completing 170,392 imported food lines examined. Explanation of why this goal was significantly exceeded: With the increase in funding, FDA was able to bring on a significant number of new investigators. Field exams play a significant role in new investigator training which resulted in exceeding the goal. Since new investigators were using these for training purposes, more resources than would normally go toward this target were utilized. Once investigators are fully trained, they will have other duties in addition to examining imported food lines. In FY 2011, FDA will retain our projected target of 160,000 due to the implementation of new field exam risk targeting procedures. The field exams will be more involved as a result of the new procedures but will result in a more focused public health outcome.
 
3.      Number of Filer Evaluations of import filers.   (214203)
 
Context: The Food and Drug Administration (FDA) receives electronic import entry data for assessing the admissibility of regulated imported articles. The accuracy of these data directly relates to the level of confidence that American consumers can expect in the quality, safety and compliance of imported articles subject to FDA’s jurisdiction. Entry data affects FDA’s determination of the labeling, quality, safety, approval status, and efficacy of FDA-regulated import articles. FDA uses an electronic entry screening system, Operational and Administrative System for Import Support (OASIS), to screen import entry data transmitted by import filers. Filers who fail an evaluation must implement a Corrective Action Plan and pass a tightened evaluation. This protects public health by ensuring reporting compliance for imported articles that FDA regulates. FDA will continue to develop and apply methods to evaluate filer accuracy that are consistent with evolving security and import regulation practices. The FY 2012 target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA exceeded this goal of 1,000 by performing 1,277 filer evaluations. This goal is an agency-wide goal and performance data includes activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program.
 
4.      Number of examinations of FDA refused entries. (214204)
 
Context:  FDA is responsible for the protection of the U.S. public regarding foods, drugs, devices, electronic products and cosmetics. This protection includes refusing entry of products into the U.S. when they are deemed violative and assuring these violative products are either destroyed or exported and do not enter into domestic commerce. Although primary responsibility for supervising destruction or exportation rests with the Bureau of Customs and Border Protection (CBP), FDA monitors the disposition of refused shipments and maintains an open file until the product is exported or destroyed. In cooperation with CBP, FDA will, at times, supervise destruction or examine products prior to export in order to assure that the refused product is actually exported. This performance goal only counts FDA supervised destruction or exportation of refused entries. In other cases FDA relies on notification from CBP that the refused products have been destroyed or exported. The FY 2009 target was increased to 5,000 examinations to better reflect the recent historical actuals for this goal. In FY 2010, the target was again increased to 7,000 to better reflect actual accomplishments.  The FY 2012 target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA exceeded this goal of 7,000 by performing 8,658 examinations of FDA refused entries as they were delivered for exportation to assure that the products refused by FDA were exported. This goal is an agency wide goal and performance data includes activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program.  Explanation of why this goal was significantly exceeded: Examinations of refused entries are a function of refusals each year. More refusals result in a larger amount of verifications. In FY 2010, there was an increased number of refusals which caused the examinations to increase as well. In FY 2012, the performance target will continue to be maintained at the FY 2011 level because there is no way to predict the number of refusals in a given year. 
 
5.      Number of high risk food inspections.   (214205)
 
Context: High risk food establishments are those that produce, prepare, pack or hold foods that are at high potential risk of microbiological or chemical contamination due to the nature of the foods or the processes used to produce them.  This category also includes foods produced for at risk populations such as infants and the immunocompromised.  The Field intends to inspect such establishments annually, or more frequently on a “for cause” basis.  The FDA inventory of high-risk establishments is dynamic and subject to change.   For example, firms go out of business, new high-risk food firms enter the market, or the definition of high risk evolves based on new information on food hazards.  High-risk establishment inspection frequencies vary depending on the products produced and the nature of the establishment.  Inspection priorities may be based on a firm’s compliance history or sample results. The FY 2009 target was increased to 6,100 inspections of high-risk food establishments to better reflect the recent historical actuals for this goal. For FY 2010, the target was increased to 6,750 to reflect the FY 2009 Appropriations.  In FY 2011, the target is being increased by 1,050 inspections for a new target of 7,800 inspections. In FY 2012, the target is being increased to 8,850 inspections.
 
Performance: In FY 2010, FDA exceeded this goal of 6,750 by performing 6,926 high-risk foreign and domestic food inspections.
 
6.      Convert data from new eLEXNET participating laboratories via automated exchange or convert data from existing manual data streams to automated data exchange. (214303)
 
Context: The electronic Laboratory Exchange Network (eLEXNET) is a seamless, integrated, secure network that allows multiple agencies (federal, State and local health laboratories on a voluntary basis) engaged in food safety activities to compare, communicate, and coordinate findings of laboratory analyses. eLEXNET enables health officials to assess risks, analyze trends and provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods. As of the end of FY 2009, there are 224 total laboratories currently participating in eLEXNET overall.  These labs include segments of a wide variety of food safety organizations on Federal, Military, State, and Local government levels.  These labs also span the agricultural, environmental, public health, veterinary, and diagnostic disciplines as well.  Of the 224 participating laboratories in all 50 states, 144 are actively entering or submitting data.  There are 44 labs among them that are fully automated via Data Exchange and transfer their LIMS sample data on a regular, ongoing basis.  The 100 other remaining laboratories enter data in eLEXNET through manual data entry.  The overall goal of the FDA's eLEXNET program is to continue to integrate those labs participating in eLEXNET via Data Exchange and to identify new labs to expand our membership.  Through continued expansion of our membership base and active data sources, the eLEXNET program will continue to serve as a key collaborative tool for food surveillance entities nationwide. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA met its performance goal by fully automating electronic data exchange between five new labs and FDA's eLEXNET (electronic Laboratory Exchange Network).  This makes the total number of automated data exchange participant labs to 44. The automated data transfer does not require any human intervention and is completely maintenance free unless there is a change in the lab environment.
 
7.      Establish and maintain accreditation for ORA labs. (214206)
 
Context: FDA is a science-based agency that depends on its regulatory laboratories for timely, accurate, and defensible analytical results in meeting its consumer protection mandate. Our laboratories have enjoyed a long history of excellence in science upon which the agency has built its reputation as a leading regulatory authority in the world health community. Accreditation of laboratory quality management systems provides a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science. Such accreditations allow FDA to maintain its reputation as a source of scientifically sound information and guidance both domestically and in the international arena.  In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA met this laboratory accreditation goal. FDA maintained accreditation for 13 laboratories: Denver District Lab, Forensic Chemistry Center, Arkansas Regional Lab, Pacific Regional Lab Northwest, San Francisco District Lab, Winchester Engineering and Analytical Center, New York Regional Lab, Southeast Regional Lab, San Juan District Lab, Detroit District Lab, Pacific Regional Lab Southwest, and Kansas City District Lab. All ORA Field Laboratories are accredited to ISO 17025 by the American Association for Laboratory Accreditation. FCC is accredited by the ASCLD (American Society of Crime Laboratory Directors).
 
8.      Increase laboratory surge capacity in the event of terrorist attack on the food supply.   (Radiological and chemical samples/week)   (214305)    
 
Context: A critical component of controlling threats from deliberate food-borne contamination is the ability to rapidly test large numbers of samples of potentially contaminated foods for the presence of contaminants. To address the need for this surge capacity, The Food Emergency Response Network (FERN), a joint effort between USDA/FSIS and HHS/FDA, was created. FERN is a nationwide laboratory network that integrates existing federal and State food testing laboratory resources capable of analyzing foods for agents of concern in order to prevent, prepare for, and respond to national emergencies involving unsafe food products. Improvements in surge capacity will have public health value even in non-deliberate food contamination by assisting FDA in identifying and removing contaminated food products from the marketplace as soon as possible in order to protect the public health and mitigate disruption in the U.S. food supply chain. FDA awards FERN Cooperative Agreements for chemistry and radiological FERN labs to the States. After receiving the funding, State FERN laboratories can take up to one year to reach full capacity due to the need for training and testing to ensure confidence in the laboratory results. As a result, labs funded in one fiscal year will not show surge capacity until the following year. With FY 2008 Food Protection increases, ORA added three additional FERN chemical labs in FY 2008 which increased the surge capacity in FY 2009 to 1,650 chemical samples per week. With the FY 2009 Appropriation, ORA added three additional FERN chemical labs in FY 2009 which increased the surge capacity to 2,100 chemical samples per week.  In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA met this performance goal surge capacity target of 2,100 chem samples per week. FDA also maintained the surge capacity for 2,500 rad samples per week. The FERN laboratories increasingly provide critical analytical surge capacity during food emergency events. An FDA assignment ("Surveillance, Inspection and Sample Collection and Analyses of Products Related to the Salmonella St. Paul Investigation" issued by ORA/CFSAN) directed samples to the FERN labs in the Salmonella outbreak in peppers, with 290 samples tested. FERN Chemistry laboratories participated in the #09-06 CFSAN Melamine Import Assignment (2008-2009), assisting FDA in the analysis of milk and protein samples, analyzing 340 samples. These FERN labs were a key factor in clearing an FDA sample backlog, which arose due to very high collection rates. FERN laboratories also participated in the FDA surveillance assignment for the political conventions. All of these efforts contribute to increasing FDA’s capacity to analyze food samples relative to biological, chemical or radiological acts of terrorism and enhance the food safety and security efforts of state, local, and tribal regulatory bodies.
 
9.      Number of foreign and domestic high-risk human drug inspections. (224201)
 
Context:  FDA is continuing to develop a more quantitative risk model to help predict where FDA’s inspections are most likely to achieve the greatest public health impact. The Risk-Based Site Selection Model provides a risk score for each facility, which is a function of four component risk factors – Product, Process, Facility, and Knowledge. In the FY 2007 model, the Agency developed several enhancements and improvements and will continue to explore ways to enhance calculations of process risk and facility sub-scores in FY 2010. As enhancements are made to FDA’s data collection efforts and to the Risk-Based Site Selection Model, FDA will improve its ability to focus inspections on the highest-risk public health concerns in a cost-effective way. For FY 2010, the target was increased to 700 to reflect the FY 2009 Appropriations. In FY 2011, the target is being increased by 50 inspections for a new target of 750 inspections. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: FDA exceeded the FY 2010 goal of 700 by inspecting 705 high-risk foreign and domestic drug manufacturers.
 
10. Number of registered domestic blood bank and biologics manufacturing inspections.  (234202)
 
Context: FDA will enhance its risk-based compliance and enforcement activities by increasing inspections of registered manufacturers of biological products, which are essential for meeting national public health objectives. These products involve complex manufacturing processes and are in limited supply in some cases. Inspections for this performance goal are conducted to ensure compliance with current Good Manufacturing Practices (cGMPs) requirements and applicable standards, and to ensure the safety, purity and potency of biological products. The biologics inventory includes blood establishments, plasma derivative manufacturing establishments, and vaccine manufacturing establishments, especially seasonal and pandemic influenza vaccines. In FY 2010, the target was increased to 1,000 inspections to reflect historical accomplishments. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA exceeded this high risk inspection goal of 1,000 by inspecting 1,073 blood banks and biologics manufacturing establishments.
 
11. Number of foreign and domestic human tissue establishment inspections.   (234203)
 
Context:  Beginning in FY 2006 as a result of new regulations, the human tissue inspection goal was created. FDA’s responsibility for enforcing the new regulations and the need to quickly assess compliance makes tissues one of the highest priorities. Two new rules took effect regarding human tissue: one requiring tissue facilities to register with FDA became effective January 2004; while the “Donor Eligibility Rule” became effective May 2005. The Field conducts tissue inspections to determine if human tissues for transplantation are in compliance with FDA tissue regulations and to assure consumer protection from unsuitable tissue products and disease transmission which may endanger public health.  In FY 2009, FDA increased this goal by 55 additional tissue inspections, over the FY 2008 target, in order to cover more of the firms that registered as a result of the new regulations. In FY 2010, the target was increased by 138 inspections to reflect the FY 2009 Appropriations. In FY 2011, the target is being increased by 15 inspections for a new target of 533 inspections. In FY 2012, the target is being maintained at the FY 2011 level.
 
Performance: In FY 2010, FDA exceeded the human tissue goal of 518 by conducting 564 inspections under new regulations.
 
12. 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 were 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.
 
13. 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.
 
14. Number of Medical Device Bioresearch Monitoring (BIMO) inspections. (253201)
 
Context: FDA’s mission includes assuring the protection of human research subjects, the quality and integrity of research, and the advancement of new medical technologies. A FDA-regulated research community that consists of Clinical Investigators, Sponsors and Monitors, and Institutional Review Boards has a shared responsibility to oversee this research in a truthful and ethical manner. For FY 2012, this performance goal continues to reflect the FY 2007 change in the selection of firms for inspection to a more risk based approach. There are no projected changes to this goal in FY 2012.
 
Performance: In FY 2010, FDA exceeded this goal of 300 by conducting 392 medical device related Bioresearch Monitoring inspections. Explanation of why this goal was significantly exceeded: Bioresearch Monitoring Inspections are conducting based on the submission of PMA applications to FDA each year. There will be no change to the goal in year to come because the increase in FY 2010 was an anomaly rather than a trend of what is to come. Historically, Bioresearch Monitoring inspections as a result of PMA applications align with the target of 300. 
 
15. Number of domestic and foreign Class II and Class III device inspections. (254201)
 
Context: The ultimate goal of preventing unsafe and ineffective devices from reaching the consumer will be advanced by detecting and intercepting unsafe and ineffective product at the manufacturing level. By utilizing risk-based inspection strategies and focusing on surveillance throughout a products life-cycle FDA will be better able to protect the public health by ensuring both the quality and effectiveness of medical devices available in the U.S. marketplace. For FY 2010, the target was increased to 1,365 to reflect the FY 2009 Appropriations.  In FY 2011, the target is being increased by 80 inspections for a new target of 1,445 inspections. In FY 2012, the target is being increased by 70 inspections for a new target of 1,515 inspections.
 
Performance: FDA exceeded the FY 2010 medical device performance goal of 1,365 by inspecting 1,659 foreign and domestic high-risk Class II and Class III medical device manufacturers.  

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