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Combined ORA Performance Goals

<< Return to FY 2007 Budget Summary

 

(These goals are repeated here to give a cohesive look at ORA)

Long Term Goal: Increase the number of safe and effective new products by increasing the predictability, efficiency and effectiveness of product development, including products for unmet medical and public health needs, emerging infectious diseases and counterterrorism.
Measure FY Target Result
1. Conduct Medical Device Bioresearch Monitoring (BIMO) inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (15025) (output) 2007 295 01/08
2006 278 01/07
2005 295 335
2004 295 354
2003 295 364
2002  290 358
Data Source: Field Data Systems.
Cross Reference: This performance measure supports HHS Strategic Goal 2.

 

Long Term Goal: Prevent harm from regulated products by increasing the likelihood of detection and interception of substandard manufacturing processes and products, through efficient and effective risk targeting, external partnering and collaboration.
Measure FY Target Result
2. Perform prior notice import security reviews on food and animal feed line entries considered to be at risk for bioterrorism and/or to present the potential of a significant health risk. (11040) (output) 2007 60,000 01/08
2006 45,000 01/07
2005 38,000 86,187
2004 NA 33,111
2003 NA NA
2002  NA NA
3. Perform import food field exams on products with suspect histories. (11036) (output) 2007 71,000 01/08
2006 73,376 01/07
2005 60,000 84,997
2004 60,000 70,926
2003 48,000 78,659
2002 24,000 34,447
4. Perform Filer Evaluations of import filers. (19015) (output) 2007 1,000 01/08
2006 965 01/07
2005 1,000 1,407
2004 1,000 1,745
2003 NA NA
2002 NA NA
5. Conduct examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported. (19016) (output) 2007 3,000 01/08
2006 2,992 01/07
2005 2,000 5,655
2004 2,000 4,905
2003 NA NA
2002 NA NA
6. Conduct postmarket monitoring, food surveillance, inspection, and enforcement activities to reduce health risks associated with food, cosmetics and dietary supplements products. (11020) (output) 2007 5,700 01/08
2006 5,963 01/07
2005 6,490 7,568
2004 6,840 7,597
2003 6,650 7,363
2002 6,650 7,442

7. Expand federal/ state/ local involvement in FDA's eLEXNET system by having laboratories submit data in the system; and, beginning in FY 2007, expand the capability of the system to provide automated notification of potential events. (19013) (outcome)

FY 2007 Measure: The number of analytes and select agents routinely tested and evaluated by eLEXNET pattern-detection algorithms such that departures from normal trends of detection trigger notifications to FDA food safety and security officials.

2007 5 analytes and 5 select agents 01/08
2006 105 labs 01/07
2005 95 labs 95
2004 79 labs 79
2003 54 labs 55
2002 NA 29

8. Increase risk-based compliance and enforcement activities to ensure drug product quality. (12020) (output)

FY 2007 Measure: The number of inspections conducted of foreign and domestic establishments identified as high-risk human drug manufacturers.

FY 2006 Measure: The number of inspections conducted of domestic establishments identified as high-risk human drug manufacturers.

2007 500 01/08
2006 483 01/07
2005 600 600
2004 376 481
2003 365 584
2002 NA NA

9. Increase risk-based compliance and enforcement activities by inspecting the highest risk registered blood banks, source plasma operations and biologics manufacturing establishments to reduce the risk of product contamination; and by conducting human tissue inspections to enforce the new regulations. (13012)

Measure 9A: The number of inspections conducted of the highest-risk registered blood banks, source plasma operations and biologics manufacturing establishments. (output)

2007 1,175 01/08
2006 1,128 01/07
2005 1,257 1,392
2004 1,319 1,444
2003 1,331 1,594
2002 1,331 1,419
Measure 9B: The number of human tissue inspections conducted to enforce the new regulations. (output) 2007 325 01/08
2006 250 01/07
2005 NA NA

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

Measure 10A: The number of inspections conducted of registered animal drug and feed establishments. (output)

2007 651 01/08
2006 618 01/07
2005 688 772
2004 703 773
2003 721 847
2002 720 804
Measure 10B: The number of targeted BSE inspections conducted of all known renderers, protein blenders, and feed mills processing products containing prohibited material. (output) 2007 527 01/08
2006 527 01/07
2005 580 588
2004 647 647
2003 880 880
2002 1305 1282

11. Utilize risk management to target inspection coverage for Class II and Class III medical device manufacturers (domestic and foreign). (15005) (output)

FY 05 Measure: Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers.

2007 1,300 01/08
2006 1,234 01/07
2005 1,104 1,265
2004 1,110  1,414
2003 1,080 1,428
2002  1,049 1,062
12. Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 7% of an estimated 2,500 firms. (15005.02) (output) 2007 NA NA
2006 NA NA
2005 175 230
2004 225 295
2003 225 225
2002 225 209
13. Establish and maintain a quality system in the ORA Field laboratories which meets the requirements of ISSO 17025 (American Society for Crime Laboratory Directors for the Forensic Chemistry Center) and obtain accreditation by an internationally recognized accrediting body (American Association for Laboratory Accreditation.) (11041) (outcome)

2007

Maintain accreditation for 13 labs

01/08

2006

Achieve and maintain accreditation for 13 labs

01/07

2005

Achieve and maintain accreditation for 6 labs

Achieved accreditation for 5 labs; maintained accreditation for 1 lab

2004

NA

1

14. Increase laboratory surge capacity in the event of terrorist attack on the food supply. Baseline and target under development. Expected completion - Sept 06
Data Source: Field Data Systems.
Data Validation: 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.
Cross Reference: These performance measures support HHS Strategic Goal 2. Performance measure 6 supports Healthy People 2010 Objectives.

 


1. Conduct Medical Device Bioresearch Monitoring (BIMO) inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (15025)

  • Context of Goal: In FY 2007, FDA plans to conduct 280 domestic and 15 foreign Bioresearch Monitoring (BIMO) inspections for a total of 295. Traditionally, FDA's approach to BIMO inspections focused on data audits of Premarket Approval (PMA) applications. While this permitted FDA to provide review divisions with a validation of the data submitted in marketing applications, these inspections were retrospective and had little impact on ongoing clinical trials. Beginning in FY 2004, FDA began assigning inspections earlier in the process, during the investigational device exemption (IDE) phase. This has a greater impact by identifying systemic problems and focusing on exploitable or vulnerable populations. The focus of these inspections is informed consent, IRB review and approval, data monitoring, and data collection rather than data verification. CDRH has approximately 1,000 active Investigational Device Exemptions (IDEs) of high-risk investigational devices (e.g., artificial hearts, drug eluting stents). FDA is interested in expanding its presence with the regulated industry through a risk-based inspection strategy. This strategy places more emphasis on (1) the detection of scientific misconduct, (2) data auditing and validation to support the device review process (greater importance on time constraints of MDUFMA and studies relying principally on foreign data), (3) innovative devices with high public health impact, and (4) vulnerable populations (elderly, minorities, pediatrics, etc.).
  • Performance: In FY 2005, FDA exceeded this goal of 295 by conducting 335 medical device related BIMO inspections.


2. Perform prior notice import security reviews on food and animal feed line entries considered to be at high risk for bioterrorism and/or to present the potential of a significant health risk. (11040)

  • Context of Goal: 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, or which may pose significant health risks to the American public, from entering into the U.S. FDA will continue to focus much of its resources on Intensive Prior Notice Import Security Reviews of products that pose the highest potential bioterrorism risks to the U.S. consumer. By FY 2007, FDA expects that the PNC will have hired a permanent staff of Reviewers and Watch Commanders that will have achieved the training and gained the experience necessary to expand its scope of targeting to include additional threat parameters.

    The PNC targets food and animal feed commodities that have been identified as high-risk based on either threat assessments that have been conducted or the receipt of specific intelligence indicating the items may cause death, illness, or serious injury due to terrorism or other food related emergencies. The PNC also utilizes the import field exams and filer evaluations by receiving feedback from the Investigators who conduct them and subsequently assessing those individuals or firms that continuously violate the prior notice regulations and the provisions set forth in the Bioterrorism Act, and further targeting those that instigate bioterrorism concerns.

    Strategies used to ensure effective targeting include:

    • Intelligence regarding countries at risk for terrorism;
    • Intelligence regarding commodities susceptible to, or exploited by, terrorism;
    • Intelligence specific to shipment or shipping entities;
    • Information gleaned from Foreign and Domestic Establishment Inspection Reports that identify security breaches;
    • Sample collection and analysis for counterterrorism;
    • Prior Notice discrepancies reported during import field exams; and,
    • Filer evaluation field audits.

    FDA anticipates that the measures that it uses to assess its success in monitoring the safety and security of imported products will continuously evolve as trade practices and information about risks change.

  • Performance: In FY 2005, FDA exceeded this goal of 38,000 by conducting 86,187 import security reviews. FDA collaborated with Customs and Border Protection to direct field personnel to hold and examine five suspect shipments of imported food; refused 141 lines of food for prior notice violations; responded to 49,649 phone and e-mail inquiries; and conducted 86,187 intensive security reviews of Prior Notice submissions out of 8,705,847 in order to intercept contaminated products before they entered the food supply.


3. Perform import food field exams on products with suspect histories. (19014)

  • Context of Goal: The events of September 11, 2001 heightened the nation's awareness of security and placed a renewed emphasis on ensuring the safety of the nation's food supply. Import food field exams, along with laboratory analyses, were FDA's major tool to physically monitor import entries prior to the enactment of the Bioterrorism Act of 2002. The role of the import food field exam and the number conducted continues to evolve as trade practices and information about risks change.

    A field examination is a visual examination of the product to determine whether the product is in compliance with FDA requirements and involves actual physical examination of the product for admissibility factors such as storage or in-transit damage, inadequate refrigeration, rodent or insect activity, and lead in dinnerware, odor and label compliance. A field exam cannot be used to test for microbiological or chemical contamination and must be supplemented with other activities.

    The volume of imported food shipments has been rising steadily in recent years, and this trend is likely to continue. FDA-regulated imports have been growing at a 19 percent annual rate. FDA anticipates approximately 12 million line entries of imported food in FY 2007 within a total of over 19 million lines of FDA regulated entries. To manage this ever-increasing volume, FDA uses risk management strategies to achieve the greatest food protection with available resources.

    FDA applies strategies that combine visual inspection for apparent labeling and other visual defects, with risk-based targeting, and selective laboratory analysis to detect chemical and microbiological hazards. FDA cannot rely solely on physical examination to reduce the potential risks from imported foods. Currently, a significant effort is underway to develop appropriate knowledge-based approaches that will give the Agency assurance that it is addressing the most serious risks.

    It is important to recognize that FDA is transforming how it regulates imports by using risk-based information technology to target physical exams and identify the need to collect samples for laboratory analysis. By focusing on risk, FDA works more efficiently to target products. An additional information technology system currently under development is an artificial intelligence tool. This new data mining tool is a risk-based automated system for screening import entries. This system will conduct continuous data mining of FDA's analytical and inspectional data and use existing business rules, multiple data sources, and artificial intelligence to identify products posing the greatest security and safety risk. The prototype will produce two risk scores for every food entry line, one for security and one for safety concerns, which will be used to immediately identify shipments that may be of high risk.

    FDA intends to expand the import data mining prototype to apply risk-based targeting of all types of regulated imports. These risk scores will help FDA target imported products for Agency action. The prototype will greatly enhance the electronic review process already in place at FDA. Entry review decisions made by FDA at border locations will be greatly enhanced by targeting products that present safety risks based on historical information and current events. While the percentage of imports physically examined may decline as imports continue their explosive growth, the exams that we conduct 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.

  • Performance: In FY 2005, FDA exceeded this goal of 60,000 by completing 84,997 field examinations of imported food lines.


4. Perform Filer Evaluations of import filers. (19015)

  • Context of Goal: 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 maintains an electronic interface with the Department of Homeland Security's Bureau of Customs and Border Protection (CBP), the Automated Commercial System (ACS). After successfully completing an initial evaluation for participation in OASIS, filers may submit import data electronically to FDA through the Automated Broker Interface (ABI) and ACS. FDA uses an electronic entry screening system, Operational and Administrative System for Import Support (OASIS), to screen entry data transmitted by filers to perform various regulatory and service functions. Such screening may assess whether FDA import personnel should review an entry further. The FDA uses OASIS to determine whether an entry should be reviewed "on screen," further supported by entry documentation; physically inspected; sampled; or permitted to proceed into domestic commerce without further evaluation. FDA can use the data in the entry system to track an imported item that negatively affected the public health.

    At a minimum, this procedure requires filers who fail an evaluation to implement an FDA-approved Corrective Action Plan (CAP) and to pass a tightened evaluation (more stringent criteria) before obtaining, maintaining or regaining the privilege of paperless filing. This protects public health by ensuring quality improvement and reporting compliance for imported articles that FDA regulates. It also ensures FDA is notified when articles appear to be violative that have previously been offered for entry.

    ORA continues to develop the policies and practices that govern monitoring filers. Expanded import activities supporting security assignments increase FDA's understanding of the problems associated with appropriate monitoring of Filer activities. FDA will continue to develop and apply methods to evaluate filer accuracy that are consistent with evolving security and import regulation practices.

  • Performance: In FY 2005, FDA exceeded this goal of 1,000 by performing 1,407 filer evaluations. This goal is an agency-wide goal and performance data will include activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program. This goal is shown in the Foods section for illustrative purposes.


5. Conduct examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported. (19016)

  • Context of Goal: Because of safety and security concerns it is important for FDA to be sure that these goods do not slip into domestic commerce but are in fact sent out of the country. FDA monitors this activity in conjunction with Customs in a category of action described as "follow up to refusals."

    If a product is refused admission, it must be destroyed or exported under Customs' supervision within 90 days of receiving the Notice of Refusal. FDA is responsible for the protection of the U.S. public regarding foods, drugs, devices, electronic products and cosmetics, and that responsibility exists until the violative article is either destroyed or exported. 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 ensure 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 product has been destroyed or exported.

  • Performance: In FY 2005, FDA exceeded this goal of 2,000 by performing 5,655 examinations of FDA refused entries as they were delivered for exportation to ensure that the articles refused by FDA were exported. This goal is an agency wide goal and performance data will include activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program. This goal is shown in the Foods section for illustrative purposes.


6. Conduct postmarket monitoring, food surveillance, inspection, and enforcement activities with the objective of reducing the health risks associated with food, cosmetics and dietary supplements products. (11020)

  • 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 highest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. We note 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, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better communicate to our stakeholders about food safety risks.

    FDA applies a risk-based strategy to the inspection of the food establishments in its inventory. High-risk foods refer to those that may contain hazards that have a high potential for causing serious adverse health consequences that would result in FDA Class I recalls. These include foods that may contain bacterial or viral pathogens, biological toxins, allergenic substances, bovine spongiform encephalopathy (BSE) infective materials, as well as foods such as infant formula and medical foods due to a potential hazard from the omission or improper fortification of the nutritive ingredients.

    High-risk establishments are manufacturers, packers and repackers of foods that include modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; soft, semi-soft, soft ripened cheese and cheese products; unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; shell eggs; sandwiches; prepared salads; infant formula; and medical foods. Additional high-risk products identified in recent years include products whose formulations do not include an allergenic ingredient but, because the product is made in a firm that also makes allergen-containing foods, may inadvertently contain an allergen which is not declared on the label. Common allergenic substances include milk, eggs, fish, crustaceans, tree nuts, peanuts or soybeans. Another class of high risk products is dietary supplements that may contain prohibited cattle-derived ingredients.

    As part of FDA's risk-based strategy, FDA recently completed a risk assessment of 23 types of ready-to-eat foods for listeriosis from the pathogen Listeria monocytogenes. This assessment ranked risk into categories from very high to low dependant on estimated risk per serving and on an annual basis. There are also foods such as shell eggs and certain produce items that are not ready-to-eat and that have caused outbreaks and are under evaluation.

    The approximate annual inspection inventory for this goal is 7,000 firms. The FDA inventory of high-risk establishments is dynamic and subject to change. For example, firms go out of business, firms start or stop making high-risk foods, and new high-risk food firms enter the market. 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. As an example, establishments will be subject to differing inspection intervals within this inspection strategy just as Low Acid Canned Food (LACF) establishments have a varying inspection cycle based on risk within the current strategy. Because domestic LACF manufacturers have a long history of exemplary compliance with FDA's good manufacturing practices and individual establishments effectively monitor their individual processing procedures, FDA believes that these establishments need to be inspected only once every three years.

    The current risk-based strategy considers food hazard information from various sources such as outbreaks, recalls, and consumer complaints as well as food analysis, epidemiological data, inspectional data and formal risk assessments. This information will be used to update currently listed commodities and establishments as well as the overall high-risk inventory of firms. The strategy includes greater inspection intervals for establishments such as cheese and LACF firms which have achieved a high level of compliance.

  • Performance: In FY 2005, FDA exceeded this goal of 6,490 by performing 7,568 inspections of high-risk domestic food establishments.


7. Expand federal/state/local involvement in FDA's eLEXNET system by having laboratories submit data into the system; and, the FY 2007 goal is updated to reflect the addition of a new and changing focus: Provide FDA food safety and security officials with notification of significant departures from normal trends of detection for 5 routinely tested analytes and 5 select agents in foods by incorporating pattern-detection algorithms into the eLEXNET system. (19013)

  • Context of Goal: 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. eLEXNET plays a crucial role in the Nation's food testing laboratory system and is an integral component of the Nation's overall public health laboratory information system.

    eLEXNET activities include:

    • Increased security-the eLEXNET program is the primary communication tool for the Food Emergency Response Network (FERN), a network of federal, state, and local food testing laboratories that will respond in the event of a terrorist incident involving the Nation's food supply. eLEXNET also handles information on methods of sample analyses and reporting of analytical results.
    • Quality-as the number of labs contributing to eLEXNET increases; it becomes increasingly difficult to ensure the quality of the data being entered. In view of the importance that DHS and the National Security Council are placing on this program, ensuring data quality and integrity is vital.
    • Outreach-eLEXNET is a storehouse of useful and timely data that enables health officials to make assessments regarding trends and risks, and provides the infrastructure for an early-warning system that identifies hazardous foods.
    • International collaboration-expansion into international partnerships and strengthening of those that are already being formed, such as the Trilateral Agreement among the U.S., Canada, and Mexico, which will result in a continent-wide food security network.

    The eLEXNET program has successfully met its laboratory expansion efforts to populate its database with valuable data for use in threat detection, risk assessment, inspection planning, and traceback analysis. To date, eLEXNET has obtained the commitment for participation from over 113 laboratories representing multiple government agencies and all 50 states. Of the 113 laboratories, 95 have contributed an extensive amount of food testing data in eLEXNET that is ready for use. By the end of FY 2006, 105 laboratories are expected to provide data into the system continuously.

    For FY 2007, the performance goal reflects the next stage in a continuum of activities that strengthen our nation's capability to proactively detect hazards in the food supply. The system will focus its efforts to package and deliver the valuable data that it has collected over the years to better assist food safety and security officials in their decision making processes. eLEXNET will incorporate algorithms and/or functionality that automatically notifies FDA and other officials when detected analytes or agents are in excess of normal trends for a range of commodities. eLEXNET anticipates that the incorporation of these features will enhance the utility of the data, improve data quality, and increase the effectiveness of the nation's food security efforts.

  • Performance: FDA met the FY 2005 goal when the system reached 95 laboratories submitting data.


8. Increase risk-based compliance and enforcement activities to ensure drug product quality. [Inspections of foreign and domestic establishments identified as high risk human drug manufacturers.] (12020)

  • 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 present the highest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. We note 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, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better communicate to our stakeholders about drug safety risks.

    For FY 2005, FDA developed a more quantitative risk model to help predict where FDA's inspections are most likely to achieve the greatest public health impact. The model includes risk factors relating to the facility, such as compliance history, and to the type of drugs manufactured at the facility. For FY 2006, FDA will continue to improve the quantitative risk model, which may also include risk factors relating to the manufacturing processes and the level of process understanding. The targets continue the trend of measuring performance toward inspecting the highest-risk establishments.

    The risk prioritization scoring methodology was applied to about 800 non-US facilities manufacturing drugs for the US market (the number of drug facilities that received an inspection by FDA in recent years). Of these 800, approximately 500 scored high enough to be included in the domestic U.S. priority. In addition, about 50 percent of all non-U.S. sites are active pharmaceutical ingredient (API) manufacturers and about 55 percent of our annual inspections are of facilities that process APIs. FDA does not inspect non-U.S. facilities at the same frequency expected for U.S. facilities.

    For FY 2007, FDA proposes to inspect, as part of this goal, a combination of both foreign and domestic facilities that are ranked the highest risk by the risk prioritization scoring model. This inclusion of foreign facilities would permit more consistent coverage of non-U.S. sites predicted to have a similar public health impact as we have experienced as a result of our inspections of domestic U.S. sites in FY 2005 and FY 2006.

  • Performance: FDA met the FY 2005 goal by inspecting 600 high-risk firms.


9. Increase risk based compliance and enforcement by inspecting the highest risk registered domestic blood banks, source plasma operations and biologics manufacturing establishments to reduce the risk of product contamination; and, by conducting human tissue inspections to enforce the new regulations. (13012)

  • Context of Goal: Inspections for this goal are conducted to ensure compliance with Current Good Manufacturing Practices (CGMPs), and to ensure purity of biological products. There are currently an estimated 2,450 establishments in the Biologics program inventory covered under this regulation. The biologics inventory includes high-risk establishments such as blood collection facilities, plasma fractionator establishments, and vaccine manufacturing establishments.

    Beginning in FY 2006, the human tissue inspections have been added to this goal because they are of high priority due to the potential for associated adverse health events. FDA's responsibility for enforcing the new regulations and the need to quickly assess compliance makes tissues one of our 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 establishment inspections and investigations to determine if human tissues for transplantation are in compliance with the tissue regulations. FDA determines if establishments are properly testing and screening tissue donors, and evaluates whether establishments are properly recovering tissues from donors as well as properly storing and transporting the tissues. Monitoring the recovery and processing of human tissue and the testing and screening of donors is critical to assure consumer protection from unsuitable tissue products and disease transmission which may endanger public health.

    Many of these firms are relatively new, small, unaware of the specifications of the new regulations, and have never been inspected previously. There are about 2,000 human tissue establishments currently registered.

  • Performance: In FY 2005, FDA exceeded this goal of 1,257 by inspecting 1,392 blood banks, source plasma and biologics manufacturing establishments.


10. 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. We note 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, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have 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 7,000 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 approximately 530. 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 (8) 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 2005, FDA exceeded this goal of 688 by inspecting 772 registered animal drugs and feed establishments; and, FDA completed the inspection of all 588 firms (8 added due to inventory increase) known to process with prohibited materials as part of a concentrated effort to prevent an outbreak of BSE in the U.S.


11. Utilize Risk management to target inspection coverage for Class II and Class III medical device manufacturers (domestic and foreign). (15005)

  • 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 highest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. We note 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, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better communicate to our stakeholders about device safety risks.

    This goal includes inspections done by FDA directly, or through state contracts or partnership agreements on Class II and III domestic and foreign medical device manufacturers. Class II and III medical devices pose the most significant risk because failures of these devices are likely to cause significant temporary or permanent injury, or death. The approximate annual inspection inventory for this goal is 8,100 domestic and foreign firms. The approximately 4,000 Class I lower-risk domestic firms are not inspected on a routine basis. These firms will be inspected on a "for cause" basis to follow up on problems identified in recalls or reported by the public.

  • Performance: FDA exceeded the FY 2005 domestic medical device performance goal of 1,104 by inspecting 1, 265 domestic high-risk Class II and Class III medical device manufacturers.

    FDA exceeded the FY 2005 foreign medical device performance goal of 175 by inspecting 230 manufacturers.


12. Utilize Risk management to target inspection coverage for Class II and Class III foreign medical device manufacturers. (15005.02)

  • Context of Goal: This goal has been incorporated with the domestic device inspection goal for FY 2006 and FY 2007. This goal includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies, although implementation of the Mutual Recognition Agreement with the EU has not been as successful as anticipated. Most choose not to participate but cite a preference for an FDA inspection. In the long term, if the MRA is successfully implemented, it could reduce the number of foreign firms that FDA will need to inspect. FDA supports a web site dedicated to MRA activities, including the implementation plan, eligible device lists, MRA meeting minutes, and the list of nominated US and EU Conformity Assessment Bodies (CABs) that are participating in confidence building activities. The web site is: http://www.fda.gov/cdrh/mra/index.html.
  • Performance: FDA exceeded the FY 2005 foreign medical device performance goal of 175 by inspecting 230 manufacturers.


13. Establish and maintain a quality system in the ORA Field Labs which meets the requirements of ISO 17025 (ASCLD for FCC) and obtain accreditation by an internationally recognized accrediting body. (11041)

  • Context of Goal: 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 will provide a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science.

    An FDA quality management system that is accredited to international standards will enable our managers to better maintain high-quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations will result in greater regulatory impact and better consumer protection. Uniform laboratory procedures will enhance data reliability and resource sharing with our domestic and international partners.

    FDA's quality management systems include risk management principles. Since laboratories receive accreditation for specific test technologies or methods, we will use risk assessment tools to determine which test technologies and/or methods will be accredited. The quality management system incorporates risk management in targeting resources and controlling processes on an ongoing basis. Targeted resources result in laboratories equipped to respond to national emergencies, food-borne outbreaks, and emerging analytical problems. Controlled processes result in documented procedures and activities that withstand domestic and international scrutiny.

    Through laboratory accreditation, FDA will maintain its reputation as a source of scientifically sound information and guidance. Other known benefits of quality systems include preservation of institutional knowledge (through process documentation and records) and increased employee satisfaction and retention. Over the long term, the quality management system implemented in FDA laboratories may serve as a model for managing other FDA regulatory and business processes. The 13 ORA Field Laboratories are currently implementing a new quality system in accordance with the updated Laboratory Manual that was issued in August 2003.

    Laboratory accreditation is an important commitment by FDA. It recognizes the need for our laboratories to have international recognition and parity; to share data and other information with other accredited labs around the world; to share a common set of policies and procedures in improving operations and harmonization; and, to provide excellent work products that are defensible and consistent. With accredited laboratories, the credibility of FDA's analytical results will be greatly enhanced, both nationally and internationally; and, the reliability of data is critical in facilitating the sharing of data and in FDA and our partners being willing and able to take regulatory actions without duplicating the analyses.

  • Performance: In FY 2005, FDA maintained accreditation for Denver District Laboratory and achieved accreditation for 5 additional laboratories: Forensic Chemistry Center; Arkansas Regional Lab; Pacific Regional Lab Northwest; San Francisco District Lab; and, Philadelphia District Lab.


14. Increase laboratory surge capacity in the event of terrorist attack on the food supply.

  • Context of Goal: 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. Once the contaminant and food vehicle have been identified through food surveillance or outbreak investigation, FDA has primary responsibility for distinguishing contaminated food products from safe food products as quickly as possible to protect public health and mitigate disruption in distribution of important foods.
  • Performance: Baseline and target under development. Expected completion - Sept 06.

 

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