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Combined ORA Performance Goals

<< Return to FY 2008 Budget Summary

 

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

The following performance goal table summarizes the performance goals, yearly targets and actual reported data for the Office of Regulatory Affairs (ORA).

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

Long Term Goal: Increase the number of safe and effective new products available to patients, including products for unmet medical and public health needs, emerging infectious diseases and counterterrorism.

Measure

FY

Target

Result

1. Focus inspectional coverage on the device research enterprise to assure the protection of human research subjects, the quality and integrity of research, and the advancement of new medical technologies.

FY 2006 Measure: Conduct Medical Device Bioresearch Monitoring (BIMO) inspections with an emphasis on scientific misconduct, data integrity, innovative products, and vulnerable populations. (15025) (output)

2008

295

01/09

2007 PB

295

01/08

2007 CR

295

01/08

2006

295

336

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)

2008

60,000

01/09

2007 PB

60,000

01/08

2007 CR

60,000

01/08

2006

45,000

89,034

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)

2008

71,000

01/09

2007 PB

71,000

01/08

2007 CR

71,000

01/08

2006

73,376

94,545

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)

2008

1,000

01/09

2007 PB

1,000

01/08

2007 CR

1,000

01/08

2006

1,000

1,441

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)

2008

3,000

01/09

2007 PB

3,000

01/08

2007 CR

3,000

01/08

2006

3,000

5,846

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)

2008

5,700

01/09

2007 PB

5,625

01/08

2007 CR

4,610

01/08

2006

5,963

6,795

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 detect and provide notification of potential

events; and, beginning in FY 2008, convert 5 data entry labs to automated data exchange. (19013) (outcome)

FY 2008 Measure: To strengthen our capability to proactively detect hazards in the food supply, eLEXNET will improve the data pool by converting laboratories that participate via manual data entry to automated data exchange.

FY 2007 Measure: To increase FDA’s knowledge base on foodborne hazards, eLEXNET will perform data analysis on laboratory results and create informational reports on specific analytes and select agents to provide FDA food safety officials more detailed information on the most common sources of foodborne illness.

2008

5 data entry labs converted to automated data exchange

01/09

2007 PB

5 analytes and 5 select agents

01/08

2007 CR

5 analytes and 5 select agents

01/08

2006

105 labs

107

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.

2008

500

01/09

2007 PB

500

01/08

2007 CR

500

01/08

2006

483

510

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 including the annual inspection of vaccine manufacturers. (output)

2008

1,175

1/09

2007 PB

1,138

01/08

2007 CR

1,053

01/08

2006

1,128

1,292

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)

2008

325

01/09

2007 PB

325

01/08

2007 CR

325

01/08

2006

250

354

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)

2008

620

01/09

2007 PB

620

01/08

2007 CR

514

01/08

2006

618

699

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)

2008

490

01/09

2007 PB

490

01/08

2007 CR

490

01/08

2006

516

516

2005

580

588

2004

647

647

2003

880

880

2002

1305

1282

11. Focus inspectional coverage on device firms to ensure consumers are protected and that the public health is advanced.

FY06 Measure: 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 III domestic medical device manufacturers.

2008

1,270

01/09

2007 PB

1,195

01/08

2007 CR

937

01/08

2006

1,234

1,299

2005

1,104

1,265

2004

1,110

1,414

2003

1,080

1,428

2002

1,049

1,062

12. 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)

2008

Maintain accreditation for 13 labs

01/09

2007 PB

Maintain accreditation for 13 labs

01/08

2007 CR

Maintain accreditation for 13 labs

01/08

2006

Achieve and maintain accreditation for 13 labs

Achieved accreditation for 7 labs; maintained accreditation for 6 labs

2005

Achieve and maintain accreditation for 6 labs

Achieved accreditation for 5 labs; maintained accreditation for 1 lab

2004

NA

1

13.    Increase laboratory surge capacity in the event of terrorist attack on the food supply. (outcome)

FY 2008 Measure: If full year FY 2007 CR occurs, no increase in surge capacity will be achieved because 3 new Chemistry (450 chemical samples per week) and 3 new Radiological Labs (1,500 radiological samples per week) will not have been funded under FY 2007 CR.

FY 2007 CR Measure: Additional surge capacity of 1,000 radiological samples per week achieved because of 2 Radiological Labs funded in FY 2006. Funding of 3 new Chemistry and 3 new Radiological Labs will not occur under FY 2007 CR.

2008

Total capacity for 1,650 chemical samples (known analyte) per week (3 new and 8 maintained Chemistry CAP Labs) & 2,500 radiological samples per week (3 new and 2 maintained Radiological CAP Labs)

01/09

2007 PB

Add capacity for

1,000 radiological samples per week (2 Radiological CAP Labs) & maintain 1,200 chemical samples (known analyte) per week

01/08

2007 CR

Add capacity for

1,000 radiological samples per week (from 2 Radiological CAP Labs funded in FY 2006) & maintain 1,200 chemical samples (known analyte) per week

01/08

2006

1,200 chemical samples (known analyte) per week (8 Chemistry CAP Labs)

Achieved 1,200 chemical samples (known analyte) per week (8 Chemistry CAP Labs)

2005

NA

0 Samples per week

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. Focus inspectional coverage on the device research enterprise to assure the protection of human research subjects, the quality and integrity of research, and the advancement of new medical technologies. (15025)
    • Context of Goal: For FY 2007, this performance goal has been revised to reflect the change in the selection of firms for inspection to a more risk based approach. It is estimated that approximately 15,000 sites conduct significant risk device research in the United States. 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. FDA expects to direct available FY 2007 inspectional resources to the following areas:
      • Directed inspections of the device research community to assure high quality and ethical research methods while the Pre-Market Approval applications (PMA) is under review.
      • Early intervention inspections of the device research community (e.g., focusing on studies during active research on vulnerable populations, with novel technology, etc.) to assure high quality and to assure that human subjects’ rights and welfare are protected.
      • Inspections initiated to investigate complaints of unethical or substandard device research practices and re-inspection of previously violative sites to assess improvements in research practices.
      • Surveillance inspections of the regulated research community using a risk-based approach for triaging and selecting sites.
    • Performance: In FY 2006, FDA exceeded this goal of 295 by conducting 336 medical device related BIMO inspections.
  1. 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. The FY 2008 goal remains at 60,000 because FDA expects that as prior notice compliance activities increase and targeting for high risk products becomes more sophisticated, the total number of intensive prior notice security reviews conducted by the PNC may decrease to a level less than the FY 2006 accomplishments. The PNC may not be fully staffed with permanent personnel as rapidly as originally anticipated.

    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 feedback from Import Investigators conducting field exams and filer evaluations and subsequently assesses those individuals or firms that continuously violate the prior notice regulations and the provisions set forth in the Bioterrorism Act and further targets 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 2006, FDA exceeded this goal of 45,000 by conducting 89,034 import security reviews. FDA collaborated with Customs and Border Protection to direct field personnel to hold and examine two suspect shipments of imported food; refused 424 lines of food for prior notice violations; conducted 105 informed compliance calls, responded to 29,220 phone and e-mail inquiries; and conducted 89,034 intensive security reviews of Prior Notice submissions out of 9,194,082 in order to intercept contaminated products before they entered the food supply.
  1. Perform import food field exams on products with suspect histories. (11036)
    • 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 17 percent annual rate since FY 2003. FDA anticipates approximately 9.1 million line entries of imported food in FY 2007 within a total of over 16.3 million lines of FDA regulated entries. In FY 2008, FDA expects approximately 9.3 million line entries of imported food within a total of more than 17.9 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.

    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 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.

    • Performance: In FY 2006, FDA exceeded this goal of 73,376 by completing 94,545 field examinations of imported food lines.
  1. 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 2006, FDA exceeded this goal of 1,000 by performing 1,441 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.
  1. 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 2006, FDA exceeded this goal of 2,992 by performing 5,846 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.
  1. 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: 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.  The Field intends to inspect such establishments annually, or more frequently for those who have a history of violations.  Once FDA has established confidence in their ability to produce a safe product, FDA will reduce the inspection frequency.  ORA will also inspect, as high risk, those establishments that produce, prepare, pack or hold foods which have been exposed to contamination as a result of natural or man-made disasters or implicated in Class 1 and some Class 2 recalls, outbreaks, injuries or illness.

    Within the FDA Food Safety Program the term high risk foods is used to denote foods that may contain hazards, after consumption, which FDA believes may have a higher potential to cause harm.  These include, but are not limited to, foods that may contain bacterial or viral pathogens; biological or chemical toxins; allergenic substances; bovine spongiform encephalopathy infective materials in foods and dietary supplements, as well as the omission or under or over fortification of nutritive ingredients in infant formula and medical foods.  The high risk foods category also includes foods identified with related serious labeling discrepancies. These foods have first priority for inspection.

    In FY 2007, this performance goal will call for 5,625 high risk establishments. A Food Defense Surveillance Assignment is slated to issue in March/April 2007. 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. The definition of high risk evolves based on new information on food hazards.  The definition is adjusted as ORA reviews the results of the Agency’s inspection efforts. 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 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. 

    • Performance: In FY 2006, FDA exceeded this goal of 5,963 by performing 6,795 inspections of high-risk domestic food establishments.
  1. Expand federal/state/local involvement in FDA’s eLEXNET system by having laboratories submit data into the 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, 135 laboratories representing multiple government agencies and all 50 states are participating in eLEXNET contributing FERN and non-FERN data into the system. Of the 135 laboratories, 107 have contributed an extensive amount of food testing data in eLEXNET that is available for reporting and analysis.

    For FY 2008, 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 improve the data pool available in eLEXNET so that results from data analysis and pattern-detection algorithms will be more statistically reliable. eLEXNET will improve the data pool by converting laboratories that participate via manual data entry to automated data exchange. The automatic data exchange program increases the quantity of samples and/or analytes a laboratory is able to submit, increases the frequency and timeliness of data submission, and ensures a better degree of data integrity compared to manual data entry. eLEXNET anticipates that increasing data exchange participation will enhance the utility of the data, improve data quality, and increase the effectiveness of the nation’s food security efforts.

    • Performance: FDA exceeded the FY 2006 goal of 105 when the system reached 107 laboratories submitting data.
  1. 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: 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. The product component relates to the intrinsic risk associated with the products manufactured at a site. The process component relates to the complexity of the processes used at a manufacturing site, the difficulty associated with controlling the processes, and the susceptibility of the processes to contamination. The facility score considers a facility’s compliance history, defect reports associated with a facility, sales production as a surrogate of production volume, and the type of establishment. The knowledge component factors in the duration since the last Current Good Manufacturing Practices (CGMP) inspection.

    For the FY 2007 model, the Agency is developing several enhancements and improvements. For example, recalls will be connected to the facilities responsible for the recalls and factored into the facility risk score. This modification will improve the risk orientation of this performance goal by increasing the risk scores of those facilities more frequently associated with product defects. During this fiscal year, the Agency will also explore ways to enhance our calculations of process risk and facility sub-scores.

    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.

    New for FY 2007, the risk prioritization scoring methodology was applied to about 2,000 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 2,000, approximately 100 scored high enough to be included in the FY 2007 FDA high risk category inspection priorities. FDA does not inspect non-U.S. facilities at the same frequency expected for U.S. facilities. With these considerations, FDA plans to inspect 500 high risk drug sites in FY 2007, including at least 25 non-US facilities high risk sites

    • Performance: FDA exceeded the FY 2006 goal of 483 by inspecting 510 high-risk firms.
  1. Increase risk based compliance and enforcement by inspecting the highest risk registered domestic blood banks, source plasma operations and biologics manufacturing establishments including the annual inspection of vaccine manufacturers 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.

    FDA will increase risk-based compliance and enforcement activities by inspecting the highest priority registered manufacturers of biological products. The highest priority firms will be those whose operations are determined to be the highest risk; new product types in need of an inspectional history to evaluate and stratify risk; and, emergency response situations.

    While all biological products represent an inherent risk, the higher risk products include those manufactured by blood banks; those manufactured by human cell, tissue and cellular and tissue-based products (HCT/P) establishments; and, vaccines, especially seasonal and pandemic influenza vaccines.

    Beginning in FY 2006, the human tissue inspections were 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 currently about 2,035 active tissue/cell establishments registered with FDA.

    • Performance: In FY 2006, FDA exceeded this goal of 1,128 by inspecting 1,292 blood banks, source plasma and biologics manufacturing establishments. In addition, FDA exceeded the human tissue goal of 250 by conducting 354 inspections under the new regulations.
  1. Ensure the safety of marketed animal drugs and animal feeds by conducting appropriate and effective surveillance and monitoring activities. (14009)
    • Context of Goal: Important features of the risk-based strategy for this goal will be reducing the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for greatest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified.  The Field notes that these goals were reported in previous years as inspection of a fixed percentage of the inventory of establishments. However, given the fluctuation in the inventory, the inspection resources available, and the risk-based prioritization approach that FDA is developing, FDA believes that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. ORA has reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better address and communicate to our stakeholders about animal drugs and feed safety risks.

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

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

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

    • Performance: In FY 2006, FDA exceeded the registered animal drugs and feed establishments’ goal of 618 by inspecting 699 registered establishments; and, FDA completed the inspection of all 516 firms known processing with prohibited materials (PM) as part of a concentrated effort to prevent an outbreak of BSE in the U.S. A total of 11 other firms known processing with PM during the previous inspection were found to be no longer processing with PM or out of business.
  1. Focus inspectional coverage on device firms to ensure consumers are protected and that the public health is advanced. (15005)
    • Context of Goal: In FY 2007 it is expected that the inventory of Class II and Class III foreign and domestic firms will approximate 8,100 firms. The ultimate goal of preventing unsafe and ineffective devices from reaching the consumer will be advanced in FY 2007 by detecting and intercepting unsafe and ineffective product at the manufacturing level through inspectional accomplishments in the following areas:
      • Inspections by assignment of manufacturers which are determined to be high risk by the Center for Devices and Radiological Health (CDRH) based upon their determination of the probability, severity and occurrence of harm to a consumer, coupled with a determination of the complexity of the device.
      • Inspections of manufacturers undergoing significant recalls, or significant adverse event reporting, to determine the root cause of the event and to limit consumer exposure. Significance is assessed by classification of the recall as a Class 1 recall or an event determined to be equivalent through a Health Hazard Evaluation performed by CDRH.
      • Inspectional follow up at manufacturers previously determined to be out of compliance with the Quality System regulation. Compliance with the regulation is necessary to ensure that safe and effective finished devices reach the consumer.
      • Inspections of foreign firms which are exporting significant devices or significant quantities of devices into the United States to reduce potential harm and exposure to the consumer.
      • Inspections of manufacturers to determine if they continue to produce safe and effective medical devices, after they have been impacted by a major natural disaster, such as a flood or earthquake.
      • Assessment inspections of firms, prior to the approval of their pre-market application. This is to ensure that firms are producing Class III devices (i.e., devices that are life-sustaining and life-supporting and those posing the greatest risk) consistent with the application being reviewed for approval, and to ensure that the requirements under the Quality Systems regulation are met, in order to minimize consumer risk to new products with no prior commercial marketing history.
    • Performance: FDA exceeded the FY 2006 medical device performance goal of 1,234 by inspecting 1,299 foreign and domestic high-risk Class II and Class III medical device manufacturers.
  1. 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 (ISO 17025 or ASCLD for FCC) 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, ORA 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 aspect of maintaining Field Laboratories. It is necessary to ensure that when laboratory deviations are identified that corrective and preventive actions are conducted and adequately documented as required by the Accrediting body. Periodic laboratory internal audits, support of annual audits by the accrediting body, proficiency testing of Analysts, annual re-qualifications of Analysts, and annual equipment qualification/calibrations as required for the maintenance of laboratory accreditation are required.

    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 2006, met this laboratory accreditation goal. FDA maintained accreditation for 6 laboratories: Denver District Lab, Forensic Chemistry Center, Arkansas Regional Lab, Pacific Regional Lab Northwest, San Francisco District Lab, and Philadelphia District Lab. FDA achieved accreditation for 7 additional laboratories: 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.
  1. 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. Improvements in surge capacity will have public health value even in non-deliberate food contamination. Identifying whether food is contaminated in a timely manner is also critical to economic stability (recovery) by providing assurance to consumers that products are safe.

    The Food Emergency Response Network (FERN), a joint effort between USDA/FSIS and HHS/FDA, is a nationwide laboratory network that integrates existing federal and state food testing laboratory resources capable of analyzing foods for agents of concern. The primary objectives of the FERN include prevention (federal and state surveillance sampling programs to monitor the food supply); preparedness (strengthen laboratory capacity and capabilities); response (surge capacity to handle terrorist attacks or a national emergency involving the food supply); and, recovery (support recalls, seizures, and disposal of contaminated food to restore confidence in the food supply). There are 135 laboratories representing all 50 states and Puerto Rico that have satisfactorily completed the FERN laboratory Qualification Checklist, which provides vital information to the National Program Office to determine if a laboratory meets the criteria for participation in FERN and is eligible for Federal funding.

    FDA has taken the lead in building capability and capacity for both Chemistry and Radiological FERN laboratories, whereas USDA is responsible for building capacity in the Microbiological laboratories. State FERN laboratories compete on a geographic basis and are awarded FDA FERN Cooperative Agreements to build this chemistry or radiological testing capacity through funding for reagents and test kits, personnel, and supplies. In addition, each Cooperative Agreement laboratory is supplied with appropriate equipment to uniformly conduct the testing. Laboratories can take up to a year to reach full capacity due to the need for training of new personnel and proficiency testing to ensure confidence of the laboratory’s results. Due to this training and confidence building period, laboratories funded in one fiscal year will not show surge capacity until the following fiscal year.

    Typically, laboratory analysis for a contaminant may involve two types of methods: screening methods, which are sensitive but which may also identify a number of false positives; and confirmatory assays, which can better confirm the presence of a contaminant. The use of screening or confirmatory methods requires time and labor and use of equipment. The measures for surge capacity are based on an identified, known analyte and the use of screening methodology. The duration at which laboratories can maintain surge capacity levels of analyses will depend upon funding availability for overtime for personnel and availability of reagents and supplies. The radiological surge capacity target was adjusted to reflect a more current assessment of surge capacity that can be funded with the FY 06 Cooperative Agreements. This current surge capacity was based on the FY 06 level of support each radiological Cooperative Agreement would provide the state laboratory, specifically the exact type and amount of equipment the laboratory would receive; the number of analysts that could be supported per shift; and, the number of quality assurance samples that would need to be performed to ensure accurate results.

    Achieving the goal of surge capacity is entirely dependant upon the funding level of FERN as surge capacity is built through State FERN laboratories who receive cooperative agreements. Without adequate funding increases to ORA’s budget to allow full funding of new cooperative agreements to state labs, ORA will not be able to continue building new surge capacity or meet the performance measures for FY 2008.

    • Performance: In FY 2006, FDA met this performance goal when the 8 Chemical Labs funded in FY 2005 achieved their surge capacity of 1,200 chemical samples (known analyte) per week. Also in FY 2006, FDA awarded Cooperative Agreements to 2 State Radiological Laboratories to develop the capacity to respond to radiological attacks on the food supply. These 2 laboratories are the basis for the increase of 1,000 radiological samples per week in the FY 2007 surge capacity goal.

 

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