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2.1.1 Program Description, Context and Summary of Performance

Three strategic goal components are identified in the Agency-Wide Section of the Performance Plan. These goal components address: streamlining the Agency for more cost-effective operations; establishing a strong emergency response capability in the event of terrorist attacks; and establishing global product safety and security. These three strategic goal components are labeled as such because they are critical elements of two broad Agency strategic goals described in Part One of the Plan [see table below].

Agency Strategic Plans	Strategic Goal Components
Improved Agency Management	Streamline FDA
Homeland Security	Emergency Preparedness & Response Global Product Safety & Security

These particular strategic goal components have been selected for discussion in this section because they set the context for unique performance goals that have agency-wide relevance.

2.1.2 Strategic Goal Components

Strategic Goal Component 1:
Streamline FDA operations to make it a more cost-effective and citizen-centered Agency.

A. Strategic Goal Explanation

FDA's Administrative Management Goals are aligned with the President's Management Agenda to modernize all Executive Branch agencies so that they are more efficient and responsive to the needs of the American Public. This will also align FDA goals with the Department's "One HHS" philosophy. These performance goals outlined below will help the Agency produce quality services in the most cost effective manner possible. This should lead to improvement in the way Agency programs serve the needs of the American Public.

Outlined below are five performance goals that focus on: reducing unnecessary reporting levels in the organization; consolidating administrative functions across the Agency; increasing the percent of FTE that are reviewed for outsourcing to private industry; increasing the percent of electronic purchases made in the Agency; improved financial management and maintaining the highest possible financial audit levels attainable. The performance goals listed below will help FDA provide more effective and efficient services to the public and regulated industry and will help the Programs accomplish their performance goals.

B.   Summary of Performance Goals

Performance Goals	Targets	Actual Performance	Reference
1. Reduce the number of review levels in the Agency to help streamline operations. (19001)	FY 04: ORA to be completed by the end of 1st quarter. Accomplishment summary due to HHS by January 2004. FY 03: Develop and implement a plan to delayer CBER, CFSAN, CDRH, OC and ORA. FY 02: Develop and implement a plan to delayer NCTR, and CVM.	FY 04: FY 03: FY 02: Developed and implemented a plan to de-layer NCTR, CVM and OC.	Strategic Management of Human Capital Efficiancy Goal
2. Implement 'shared services' concept and consolidate selected functions in the agency. (19002)	FY 04: Implement the Shared Service organization for those functional areas transferred to the organization. FY 03: Begin implementation of shared services concept in accordance with the BAH Administrative Consolidation Study. FY 02: Award contract of administrative functions to be completed by September 2002 with the Human Resources portion completed by May 2002. FY 01: NA	FY 04: FY 03: FY 02: Completed Agency-wide assessment of administrative services. FY 01: Merged Management Initiatives Staff and Evaluation Staff within the Office of Planning FY 00: Abolished three OC Offices: OEA/IO, ISCAS, and OHA.	Strategic Management of Human Capital Efficiancy Goal
3. Increase the percentage of Commercial FTE that will be reviewed for outsourcing.(19003)	FY 04: 10% or 146 FTE FY 03: 10% or 145.7 FTE FY 02: 5% or 72.7 FTE	FY 04: FY 03: FY 02: 4% or 57.7 FTE	Competitive Sourcing Efficiancy Goal
4. Increase the percentage of electronically purchased transactions.*(19004)	FY 04: 92% FY 03: 91% FY 02: 89% FY 01: 87%	FY 04: FY 03: FY 02: 93.5% FY 01: 90.5% FY 00: 93.6% FY 99: 93.5%	Expanded ElectronicGovernment Efficiancy Goal
5. Maintain a clean (or unqualified) audit opinion with no material weakness. (19005)	FY 04: Yes FY 03: Yes FY 02: Yes FY 01: Yes	FY 04: FY 03: FY 02: Yes FY 01: Yes FY 00: Yes FY 99: Yes	Improved Financial Management Efficiancy Goal
6. Increase percentage of contract dollars allocated to performance based contracts (19006)	FY 04: 40% FY 03: 30% FY 02: 25%	FY 04: FY 03: FY 02: 25.5% FY 01: 23.6%	Budget & Performance Integration Efficiancy Goal
7. Establish an Agency-wide Enterprise Architecture (EA). (19009)	FY 04: Complete next phase (i.e., critical business and data process that is next in line in priority) of the EA, leveraging outcome of EA developed for CT, Administrative and PDUFA business processes. FY 03: Complete EA for identified CT and PDUFA business purposes; implement Agency-wide EA governance. FY 02: Obtain FDA leadership buy-in; award contract for EA development support; initiate the establishment of an EA framework.	FY 04: FY 03: FY 02: Completed all goals	Expanded Electronic Government Efficiancy Goal
8. Expand the Agency-wide IT security program to ensure all of Agency's IT assets that support the Agency's business processes are in compliance with the Government Information Security Reform Act (GISRA). (19010)	FY 04: Continue to ensure 100% compliance of the FDA IT infrastructure and assess the next third of the major systems for GISRA compliance, and perform appropriate risk mitigation. FY 03: FDA is expected to assess 100% of the FDA IT infrastructure and one third of the major systems for GISRA compliance and provide any needed corrections. FY 02: NA	FY 04: FY 03: FY 02: 100% - The FDA performed comprehensive assessments of OC and NCTR, as well as GISRA compliance reviews of selected major applications and critical IT services	Expanded Electronic Government Efficiancy Goal
9. Implement Financial Enterprise Solutions, FDA's version of UFMS. (19017)	FY 04: Complete systems preparation to implement Financial Enterprise Solutions starting with General Ledger, payroll, Travel Manager FY 03: Begin data cleanup and preparation for conversion of existing systems to new financial system FY 02: Prepare for consolidation of accounting operations in the ORA regions reducing the number of payment centers from 15 to 1; standardize on financial system use throughout FDA for accounts payable and Travel.	FY 04: FY 03: FY 02: 100% - The FDA performed comprehensive assessments of OC and NCTR, as well as GISRA compliance reviews of selected major applications and critical IT services	Improved Financial Management Efficiancy Goal
TOTAL FUNDING:* ($ 000)	FY 04: 116,360 FY 03: 104,752 FY 02: 94,086 FY 01: 80,126 FY 00: 78,120	Numbers in the Reference column corresponds to the relevant strategic goal in the HHS Strategic Plan

^* These goals are crosscutting goals with resources allocated across programs that are reflected as part of program resource totals.

C. Goal-By-Goal Presentation of Performance

1. Reduce the number of review levels in the Agency to help streamline operations. (19001)

Context of Goal: FDA is striving to reduce the number of review levels for decision making within the Agency to no greater than four, which is consistent with the President's management initiatives and Departmental guidelines. The wording of this goal has therefore been revised so that the goal is linked to the department consolidation initiative. Reduction of review levels will allow for a more effective structure and a streamlined organization, as well as increase the span of control to some extent for managers across the Agency. There are, however, limits to span of control ratios at FDA. This is because FDA is a knowledge-based organization, which utilizes complex scientific systems and oversees research activities. Large spans of control are generally more appropriate for production and transaction-based organizations. FDA managers are frequently managing research and development or scientific activities, where large spans of control are not possible or desired.
Performance: As of October 2002, the Center for Veterinary Medicine, the National Center for Toxicological Research, and the Office of the Commissioner have eliminated organizational components below the fourth management level. Additionally, in FY 2002, FDA has consolidated from seven Personnel Offices to one and FDA has completed the review for the Center for Devices & Radiological Health. The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Food Safety and Applied Nutrition are scheduled to be completed by the end of FY 2003. ORA is scheduled for review during the first quarter 2004.
Data Sources: FDA Organizational charts, personnel databases, and functional matter experts.

2. Implement shared services concept and consolidate selected functions in the Agency. (19002)

Context of Goal: FDA is aligning itself with departmental guidelines for the consolidation of selected functions across the Agency. As the departmental consolidation and streamlining plan progresses, the FDA consolidation effort can be further clarified. FDA has already taken major steps towards the consolidation of selected functions across the Agency in FY 2000 and FY2001. In FY 2002 and FY 2003, FDA is tying in further administrative management consolidation efforts with the Department's Plan. By the end of FY 2002, an assessment of administrative services was completed and preliminary recommendations for organizational structure were made. In FY 2003, detailed process design and organizational design work will be done to ensure the shared services organization is positioned to provide the highest level of service to customers in the most efficient way. Targeted date for "stand up" of the shared services organization is October 1, 2003 (FY 2004). The Shared Services Organization will be a customer-focused organization in which business units establish service priorities and services will be tailored to meet the individual needs of business units. Service level agreements will be drawn between administrative service providers and customers [business units]. Business units will be defined as the various FDA programs- e.g., Foods, Human Drugs, Animal Drugs and Feeds, etc. The shared service organization will be governed by a group which will include representatives of both providers and customers. In FY 2003, the governance infrastructure will be put into place to facilitate the migration from current organizational structure and service delivery methods to the shared services model of service provision. Performance will be monitored against 'best practices' in internal and external organizations. The shared services model will help FDA to focus on its 'core business', create satisfied customers and employees; leverage technology and information; and more effectively manage costs. The 'shared services' initiative is considered as a complementary strategy to administrative consolidation. Together, the two strategies should lead to a more effective organization which is guided by unified policies, implements cost-effective processes and provides customer-responsive services.

• FY 2004: Refine cost structures and service level agreements under shared service organization.
• FY 2003: Consolidate the following administrative management functions:
  • Personnel
  • Procurement
  • Facilities
  • Grants
  • Information Technology
• FY 2002: Eliminated a Deputy Commissioner position Moved all remaining components under Deputy Commissioner to current senior managers
• FY 2001: Merged the Management Initiatives Staff with the Evaluation Staff

Performance: FDA completed an Agency-wide assessment of administrative services to prepare for implementation of the shared services initiative. FDA has combined the Management Initiatives Staff with the Evaluation Staff and has also reduced the number of Deputy Commissioners from four to two. By the end of FY 2001, FDA met its FY 2003 schedule to eliminate all targeted positions except the Principal Deputy Commissioner, as the Deputy Commissioner for International and Constituent Relations retired in September 2001. FDA is currently taking steps to consolidate certain administrative functions within the Agency by FY 2003.
Data Sources: FY 2001 FDA Workforce Restructuring Plan

3. Increase the percentage of Commercial FTE that will be reviewed for outsourcing. (19003)

Context of Goal: FDA has contracted for many of its commercial requirements and will continue to contract commercial work and identify in-house activities for competitive sourcing. In FY 2002, FDA studied the following commercial activities: graphic arts/visual information services, medical/scientific library services, web publishing, and a television studio in the Center for Devices and Radiological Health. These activities represent 5% of FDA's commercial FTEs on our 2001 FAIR Act Inventory. In FY 2003 FDA will study the following activities, representing an additional 10 percent of the agency's commercial FTEs: general accounting in the Office of Regulatory Affairs field components, biological technician and physical science technician services, and facilities/real property management services. We estimate that our FY 2004 target for competitive sourcing will be at least 10%. The total amount of positions studied will reach a total of 25% by the end of FY 2004.
Performance: FDA studied 4% or 57.7 commercial FTEs for outsourcing in FY 2002. FDA originally planned to study its web design and development activities, which included approximately 46 FTEs. However, due to the HHS and FDA IT consolidation, FDA decided to postpone a study of web design and development and instead, to directly convert the small amount of web publishing work that is not contracted out, approximately 3 FTEs. The agency expects to have approximately 36 contractible FTEs from the web design and development study. FDA also expects 57.8 contractible FTEs from our FY 2002 studies, instead of 76. FDA's FY 2003 studies will yield 167.4 contractible FTEs, which will result in achieving our 15% competitive sourcing goal by September 2003.
Data Sources: FDA Office of Management & Systems, 2001 FAIR Act InventoryIncrease the percentage of electronically purchased transactions.

4. Increase the percentage of electronically purchased transactions. (19004

Context of Goal: The targets for FDA for FY 2001, FY 2002 and FY 2003 are departmentally mandated targets for HHS. FDA expects to significantly exceed these targets in all years. The percentages are not representative of all purchases, but reflect the percentages of purchases made electronically that were eligible for electronic purchase. The figures represented above also reflect the percentages of transactions and not the percentages of dollar purchases. In examining the departmental definitions for these categories, we discovered that the FY 2000 Target is defined differently than the targets in the other years (FY 2001, FY 2002, and FY 2003). It is also defined differently than the Actuals for FY 2000, thereby making it non-comparable.
Performance: Ninety-three percent of eligible transactions were purchased electronically in FY 2002. FDA expects this figure to grow and also expects to exceed the departmental targets given to FDA. The Agency is conscientiously seeking to use the IMPAC Card instead of a purchase order for buying items under $2,500. By using the IMPAC Card, the Agency lowers the $90.00 overhead cost for each purchase. This then has led to the Agency exceeding its goal for FY 2002 as expected.
Data Sources: FDA Small Purchase System, statements from bank card company

5. Maintain a clean (or unqualified) audit opinion with no material weakness. (19005)

Context of Goal: An unqualified audit opinion is a statement by the auditors that an entity's financial statements present fairly, in all material respects, the financial position, its net costs, changes in net position, budgetary resources, and reconciliation of net cost to budgetary obligations for the year ended, in conformity with generally accepted accounting principles. A financial statement material weakness is a significant finding which, in the opinion of the auditors, poses a risk or threat to the internal control systems of an audited entity.
The table listed below shows additional relevant historical information regarding FDA's prior financial performance and reflects the results of the steps FDA took to get to its current condition. In FY 1997, FDA had 5 reportable conditions, 3 material weaknesses, did not have an unqualified audit opinion, and was not timely provided. Since then, FDA has managed to progressively perform at a higher level.
Performance: FY 2002 Performance is at 100 percent. Since FY 1997, the performance has steadily improved due to FDA taking many corrective actions, including establishing a branch organized in FY 2000 in the Division of Accounting to prepare financial statements and to interact with the auditors. As a result, FDA went from not having an unqualified opinion with three material weaknesses and five reportable conditions in FY 1997 to having an unqualified opinion with no material weakness and one reportable condition in FY 2001. The remaining reportable condition deals with the information systems controls of FDA's financial management systems. FDA is actively taking corrective actions to resolve this condition. The sole instance of non-compliance with laws and regulations dealt with FFMIA compliance. To achieve compliance with FFMIA and the Secretary's directive, FDA is working with HHS and other HHS components to develop and implement the Unified Financial Management System (UFMS), which will meet federal system requirements. Where possible the Agency has improved its performance as seen in the chart above. In those areas where the FDA has remained stable, it is anticipated that the Financial Business solutions will lead to improvements.
Data Sources: Fiscal Year 2001 FDA Chief Financial Officer's Annual Report.

6. Increase percentage of contract dollars allocated to performance based contracts. (19006)

Context of Goal: FDA is aligning itself with Departmental and OMB goals of awarding 20 percent of eligible contract dollars to firms using performance based contracts by FY 2002. This increase will lead to greater accountability of services provided by contractors, and increased efficiency. FDA exceeded the 20 percent target set by OMB in FY 2001 and set, more ambitious targets each subsequent year. It should also be noted that not all contract dollars will be eligible for this initiative.
Performance: Twenty-five percent of eligible contract dollars were awarded as performance based contracts during FY 2002, significantly exceeding the Department's goal. The Agency has historically set the example for HHS OPDIVs implementing performance based contracts; therefore FDA was able to meet the Department's goal. FDA reviews each contract to determine if it is a candidate for performance based contracting. If so, the Agency provides the contract's objectives and requests the contractor to provide the method(s) to meet the objective. Once the Agency and contractor agree, FDA personnel regularly evaluate the contractor's performance. If necessary, the Agency invokes a previously negotiated financial penalty against the contractor for failing to meet the objective(s). This allows the Agency and contractor to assure high performance.
Data Sources: The Agency will rely on the data system developed and maintained by the Department of Health and Human Services. This database classifies contracts based on whether they use performance contracting. The Agency receives periodic reports that classify the percentage of contracts that are performance based.

7. Establish an Agency-wide Enterprise Architecture (EA). (19009)

Context of Goal: Clinger-Cohen, the President's Management Agenda, the Department's policy of "One HHS" and PDUFA III are the mandates driving the Agency towards the establishment of an EA. In addition, the EA is a major piece of the Agency's overall strategy in support of the CT program: it will provide the framework on which data can be standardized and integrated to enable real time access of information crucial to the CT effort.
Performance: For FY 02, $5 million has been allocated for the development of an Agency-wide Registration System. This will be accomplished through the development of an EA as a first step, with associated CT business processes receiving priority. A contract is expected to be awarded and work initiated in FY 02. For FY 03, it is expected that the EA will be completed for those CT processes, although the impact of the new Foods Registrations system that has been approved as part of the CT bill has not been determined.
Data Sources: EA Strategic Plan and Project Plan; progress reports to HHS, OMB and industry (PDUFA status reports)

8. Expand the Agency-wide IT security program to ensure all of Agency's IT assets that support the Agency's business processes are in compliance with the Government Information Security Reform Act (GISRA). (19010)

Context of Goal: GISRA has set requirements for Agency's to identify their key IT assets, assess them for security vulnerability and address any findings. Security is also part of the Department's overall IT Security program. As a result, the Agency is centralizing the security program to ensure security efforts are performed in a uniform and consistent manner, while at the same time leveraging efficiencies (bulk buys, Agency-wide contracts, etc.) that are only possible with Agency-wide scope.
Performance: In FY 01, the GISRA assessment identified vulnerabilities that were partly the result of inconsistent interpretation and application of security policies across the Agency. In FY 02, FDA assessed OC, NCTR and selected other critical components for GISRA compliance and resolved any access control issues. In FY 03, FDA is expected to assess 100% of the IT infrastructure and one third of the major systems for GISRA compliance and provide any needed corrections.
Data Sources: Annual GISRA assessment and report

9. Implement Financial Enterprise Solutions, FDA's version of UFMS. (19017)

Context of Goal: FDA is complying with the department's goal to establish a unified financial management system. Specifically, the Department plans to utilize two accounting systems: one for the Center for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration, and one serving the National Institute of Health (NIH), the Program Support Center (PSC) and its eight servicing OPDIVs, the Center for Disease Control and Prevention (CDC) and FDA. FDA will use the FY 2004 increase to complete the preparation to implement the general ledger and accounts payable systems. The goal of the UFMS project is to reduce costs, mitigate security risks, and provide timely and accurate information across DHHS. FDA will acquire and implement a new core financial management system as part of the UFMS project in FY 2005. Implementing a new financial system will provide qualitative and quantitative benefits to FDA because it will achieve improved business processes and provide more accurate and timely information to better support FDA's and DHHS' mission.
Performance: FDA has begun setting up the implementation team for Financial Enterprise Solutions, FDA's name for the Unified Financial Management system.
Data Sources: The sources are encompassed in the General Ledger & Federal Administrator, the Purchasing & Accounts Payable; and the Accounts Receivable. These sources are being prepared to transition to the Financial Business solutions system.

Strategic Goal Component 2:
Enhance the Agency's emergency preparedness and response capabilities in the event of a terrorist attack.

A. Strategic Goal Explanation

This strategic goal represents one of four key goals contained in FDA's strategic and action plans for Counterterrorism. The other three goals in the Agency's Counterterrorism Plan address: deterring, detecting, investigating and interdicting terrorist threats; assuring the availability of medical counter measures; and ensuring the safety of radiological products used in terrorist scenarios.

The emergency preparedness and response goal was singled out for discussion in this Agency-wide section of the Performance Plan because the subject matter has immediate relevance throughout all organizational components. Emergency preparedness, in particular requires a centralized focus because a well-conceived and unified response to outside threats is crucial for success. FDA's emergency preparedness and response capability will help the Agency respond effectively to a wide range of terrorism-related emergencies. Key strategies necessary to achieve this goal include:

• Preparing an Agency-wide emergency preparedness and response plan which can serve as a general blueprint for action. The Agency Plan includes general protocols such as roles to be played by different agency and outside actors, criteria for escalating responses to terrorist crises, general procedures for accessing needed medical products, and approaches to securing human and physical assets. Specific emergency plans to respond to particular incidents can be patterned after the general Agency plan. (Performance Goal # 10) Within this Performance Plan additional performance goals have been formulated to develop emergency preparedness plans that respond to specific types of crises. See Goal # 15 in the Human Drugs Section; and Goal # 13 in the Medical Device and Radiological Health Section. Within individual program sections of the Performance Plan
• Developing an emergency operations network which links people and information necessary to make crucial command decisions in the event of a terrorist attack. The emergency operations network requires both the organizational and information infrastructures to work in an integrated fashion in order to be effective. (Performance Goal # 12)
• Establishing an emergency laboratory response network that can quickly and accurately share analytical results of pathogen or hazard testing between federal and state laboratories. A critical component of this network is the electronic exchange network (eLEXNET), which will allow at least 79 federal and state laboratories to be contributing analytical data to the system by FY 2004. (Performance Goal # 13); and
• Establishing continuity-of-operations plans that will allow FDA to continue critical operations in the event of an attack on the Agency and its assets. These contingency plans will provide for continuity and dependability of operations as it relates to Agency leadership, essential program activities, protection of information and physical assets, and maintaining a capability to run the emergency operations system at an offsite location.

B.   Summary of Performance Goals

C. Goal-By-Goal Presentation of Performance

10. Expand federal/state/local involvement in FDA's eLEXNET system by having 79 laboratories participate in 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. The eLEXNET System plays a crucial role in the Nation's Food Safety laboratory system, and it is an integral component of the Nation's overall public health laboratory information system. That system encompasses CDC's Laboratory Response Network, and FDA's Food Emergency Response Network, which is a collaborative activity among FDA, CDC and FSIS.
FDA is developing eLEXNET as a key component of a total food laboratory response network that is intended, ultimately, to cover foods, drugs and biological products; and have the capability to test for the presence of biological, chemical, radiological and physical hazards. The larger network, which is patterned after CDC's laboratory response network, encompasses several collateral functions that complement data exchange proficiency levels in sample analysis and testing.

The difference in the systems is that CDC collects human samples, while FDA collects product samples. FDA patterns its system after some of the principles used by CDC. These include:

• A workload management system which matches the flow of laboratory samples with the capacity of the laboratories that participate in the network;
• A protocol which provides for 'proficiency testing' of all samples that are included in the network;
• A system for ensuring the availability and quality of reagents used in laboratory analysis;
• A system for encouraging the development of new methods which are necessary to assess risks in anomalous or novel situations; and
• A rigorous training initiative to ensure that all analysts are at high

Performance:eLEXNET was released as a proof-of-concept system in FY 2001 to 14 laboratories (7 regional FDA, one regional USDA, and 6 state and local agriculture and public health laboratories). The system has expanded to include new laboratory partners in FY 2002, and by September 30, 2002, a total of 51 laboratories are actively submitting data to eLEXNET. The eLEXNET partnership will expand to include at least 54 laboratories submitting data to the system at the end of FY 2003. An additional 25 laboratories will be submitting data to the system by the end of FY 2004.
Data Sources: ORA will track the number of participating eLEXNET laboratories.

11. Enhance the Agency Emergency Preparedness Plan to establish protocols for responding to terrorist attacks.(19008)

Context of Goal: The Agency Emergency Preparedness Plan establishes an overall blueprint for FDA to follow in the event of a terrorist incident. The Plan is sufficiently generalized so that it can be tailored by individual Agency Programs to meet the needs of particular categories of events, including biological, chemical, physical or nuclear threats. In order to address these kinds of threats, the Agency must anticipate which FDA-regulated products are the most likely weapons; which harmful agents are the strongest candidates for weaponization; and which points in the pipeline are the most vulnerable to attack. Then steps must be taken to reduce the vulnerabilities at these points. If any part of the system is breached, FDA must have the appropriate medical products and emergency response plans in place to minimize harmful impacts.
Performance: This goal is new for FY 2004. The Radiological Emergency Response Plan, issued March 2002 (draft 1), is currently being redrafted based on comments received and exercises conducted. The Chemical and Biological Emergency Response Plan, issued June 4, 2002 (draft 1), is currently being redrafted based on comments received and bioterrorism exercises conducted in FY 02. CFSAN contracted for a "Food and Cosmetics Chemical, Biological, and Radiological Threat Assessment," document which addresses the more specific issues of potential agents that may affect FDA products.
Data Sources: Office of Emergency Operations.

12. Assure continuity of FDA operations in case of an emergency.(19007)

Context of Goal: In light of the September 11, 2001 events, the Agency decided to develop a Continuity of Operations Plan (COOP) to assure the continuance of minimum essential functions across a wide range of potential emergencies. Executive Order 12656, Presidential Decision Directive 67 and Federal Preparedness Circular 65 reinforce this objective.
Performance: In FY 2002, FDA participated with PSC to develop a COOP Plan for the Parklawn Building. In addition, the FDA let a contract to develop a Continuity of Operations Plan for the Washington DC area offices (Phase I) and for FDA Regional and District Field Offices (Phase II). The COOP plans will be reviewed and enhanced regularly.
Data Sources: Office of Crisis Management, Security Operations, Policy and Planning

Strategic Goal Component 3:
Establish a system of global product safety and security that will assure the safety of FDA-regulated products regardless of their point of origin, pathway or final destination.

A. Strategic Goal Explanation

There is consensus that FDA can no longer just look at products as they cross the border but rather that we must hold the foreign manufacturer and importer responsible for the safety and efficacy of their products. To do this we must look at products from point of production, through shipment to the U.S., at the border, and through to the U.S. manufacturer and/or ultimate consumer. This expanded import life cycle is essential to successfully protecting domestic commerce from unsafe imported products. FDA is developing an Import Strategic Plan to reinvent the import process.

The reinvention process will focus on the extended life cycle of an import. While the Agency currently does some foreign inspections, engages in some education efforts, and participates in international agreements, our ability to ensure that production controls are in place for imported goods is limited. For the most part, FDA's current review of imported goods - the life cycle -- starts with the shipper and ends with the Customs broker or importer.

In order to protect the public from unsafe imports, the Agency must extend the life cycle. This means understanding what is happening with the product beginning with the raw materials, through the foreign manufacturers, carriers, and shippers, past the broker and importer, and all the way through to the distributor, consignee, domestic manufacturer (in the case of unfinished product), retail and to the ultimate consumer. The Agency must identify what data exist all along the extended life cycle of an imported product that signal the appearance of a processing problem and integrate those data for use in the entry review process.

The three goals below are designed to develop risk assessment and control strategies for imported products at FDA's traditional focal point entry across the border. These goals address the data integrity of the automated system that is used for initial screening of import entries and delves into various features of trade practices including the monitoring of goods refused in cooperation with the U.S. Customs Service.

B. Summary of Performance Goals

C. Goal-By-Goal Presentation of Performance

13. Perform 48,000 physical exams and conduct sample analyses on products with suspect histories. (19014 - this goal is repeated as number 11036 in the Foods Section)

Context of Goal: In FY 2004 FDA will focus much of its resources on examination and follow-up on import shipments that pose the highest potential risks. Increases in the number of physical examinations will not continue to grow at the rate expected in FY 2002 and 2003. Given the continuing explosion in number of import shipments to this Country, it is not realistic to expect that FDA can keep up with the volume by simply expanding the number of physical examinations. Rather, a significant effort will be launched to develop the appropriate knowledge-based approaches that will give the Agency assurance that it is, in fact, addressing the most serious risks. Finding these risks is a great challenge considering that FDA-regulated imports have grown at 10 to 12% annual rate for several years, and may originate in any of more than 100 countries, many of which have regulatory systems in place which are much more primitive than that found in the U.S. The risk has now been exacerbated in light of security concerns raised by terrorism and counterfeiting incidents.
During FY 2003 FDA will develop a more robust physical examination approach that merges the assessment of information integrity with the safety and security of the product. By FY 2004 FDA will have in place a new version of the import field exam. The new exam will routinely include: verification that the imported product is the same as that which was declared; assessment of security concerns related to labeling and source country; and traditional safety concerns. More importantly, these new exams will be conducted on import entries selected using a more rigorous risk assessment and management rubric. FDA will be developing during FY 2003 the criteria and, to the extend possible, the computer systems to be able to better identify, obtain, process, assimilate, and deliver data relating to an imported product's safety and security. This data will be delivered in a more meaningful and timely fashion to the primary decision makers in FDA's import process located at the borders and throughout the country monitoring imports electronically through OASIS. During FY 2003 FDA will pilot various features to develop a feasible implementation process, and to develop better time estimates so that appropriate resources can be matched with the revised approach. FDA will use a risk-based system to target suspect problem areas. Such areas may include:

• Filer Evaluation Field Audits;
• Pilot with filer evaluation, importer/trader inspections;
• Warehouse blitz programs;
• Transshipment-targeted field examinations;
• Sample collection and analysis for Counterterrorism;
• Implementation of program with Canada and Mexico to enhance advanced identification of transshipped cargo; and
• Expand in-bond entry evaluation including performing examinations of in-bond entries at port of arrival and port of entry or export.

During FY 2003 FDA will gather information about the number and characteristics of these potential targets so that by FY 2004 pilot programs can be identified with enough examination of each type so that practices can be revised again in subsequent years to reflect lessons learned. 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. During FY 2003 FDA will also decide on the appropriate methods including summary categories, if appropriate, that are best suited to track various components of this goal. Additional risk based candidates may be identified that will require further pilot studies in FY05 and later.
Performance: This goal was new for FY 2002 and FY 2003. The FY 2002 performance was 800 new investigators and analysts hired and 34,447 physical exams conducted. The FY 2001 baseline was 12,169 physical exams. The FY 2002 goal targets 24,000 exams that target doubles to 48,000 in FY 2003. The FY 2004 goal remains at 48,000 because resources will be devoted to targeting and following through on suspect import entries rather than significantly expanding import coverage.
Data Sources: Field Data Systems

14. Perform at least 1,000 Filer Evaluations under new procedures. (19015)

Context of Goal: 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 United States Customs Service's (Customs) 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 updated 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 insuring 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.
During FY 2003 ORA will continue to develop the policies and practices that will govern the implementation of a new version of the filer evaluation. The new filer evaluation will issue pilot testing assignments that are designed to refine practices and assess the amount of time that will be required to perform these evaluations. During this time FDA will develop a risk based stratification plan to determine the frequency of filer evaluations. During FY 2003 it is anticipated that FDA will develop, at minimum, an interim way to track filer evaluations with plans and a timeline to fully integrate the collection of data on this activity into field data systems.
Performance: This goal is new for FY 2004. There is no baseline data because the Field data systems do not capture this activity in FY 2002. Filer evaluations will be substantially modified for FY 2004 to reflect increasing needs to assess data integrity.
Data Sources: Field Data Systems

15. Conduct 2,000 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: In FY 2001 FDA refused about 18,000 products offered for import entry into the U.S. 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, or within such additional time as specified by Customs. 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 U.S. Customs, FDA monitors the disposition of refused shipments and maintains an open file until the product is exported is exported or destroyed. In cooperation with Customs, FDA will, at times, supervise destruction or examine products prior to export in order to ensure that the refused product is actually exported. In other cases FDA relies on notification from Customs that the refused product has been destroyed or exported. During FY 2003 will continue to develop the policies and practices that will govern the monitoring of the export of refused goods, issue pilot assignments that are designed to refine practices and assess the amount of time that will be required to perform these evaluations. During FY 2003 it is anticipated that FDA will develop, at minimum, an interim way to count these events with plans and a timeline to fully integrate the collection of data on the export of refused entries into field data systems.
Performance: This goal is new for FY 2004. There is no baseline data because the Field data systems do not capture this activity in FY 2002. As of May 2002 FDA estimates that it has performed 800 similar exams.
Data Sources: Field Data Systems

Contact Information:
Planning Staff, Office of Planning, FDA
Phone: 301-827-5210

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