U.S. Food and Drug Administration
Performance Plan
2002

Part 2: Performance Plan and Report
Introduction

Part 2: Performance Plan and Report presents updated FY 2003 and final FY 2002 performance goals, along with the FY 2001 Performance report and an update on performance for some FY 2000 goals for each of FDA's programs.

In this section of the Plan, readers will be able to obtain greater detail to support their understanding of the key Performance goals described in Part One.

Each program section includes the following information:

• Total program funding
• A broad description of program activities
• Strategic goals
• Approaches for achieving goals
• A performance goal summary table; and
• A goal-by-goal explanation including some updated FY 2000 results.
• A verification and validation section which addresses sources and quality of data used in the plan.

The following sections will be covered:

Administrative Management -- Ensures that FDA provides the highest quality of service possible to the public by managing its resources effectively and efficiently in alignment with the Departmental Plan.

Foods -- Promotes and protects the public health and economic interest by ensuring that the food supply is safe, nutritious, wholesome, and honestly labeled. The program also ensures that cosmetics are safe and properly labeled.

Human Drugs -- Ensures that all drug products used for the prevention, diagnosis, and treatment of disease are safe and effective; and that information on proper use is available to all users.

Biologics -- Ensures the safety, potency, and effectiveness of biological products for the prevention, diagnosis, and treatment of disease. This includes blood and blood products, blood test kits, vaccines, therapeutic agents, and other biological products.

Animal Drugs and Feeds -- Ensures that only safe and effective animal drugs, devices, feeds, and food additives are marketed; and that foods from animals that are administered drugs are safe for human consumption.

Medical Devices and Radiological Health -- Ensures that medical devices are safe, effective, and properly labeled; and that the public is not exposed to unnecessary radiation from medical, industrial, and consumer products.

National Center for Toxicological Research -- Conducts scientific research to develop methods for regulatory applications.

2.1 ADMINISTRATIVE MANAGEMENT

2.1.1 Program Description, Context and Summary of Performance

Total Program Resources:

FDA's Administrative Management Performance Goals are aligned with the Departmental Plan and focus on making the FDA more citizen-centered and efficient. These performance goals will help the agency produce quality services in the most cost-efficient manner possible.

2.1.2 Strategic Goals

Strategic Goal 1: Provide for a streamlined and efficient hierarchy within the Agency that is more efficient and effective and ties in with Department goals.

A. Strategic Goal Explanation

Outlined below are five performance goals that focus on flattening the workforce and increasing the span of control for managers, 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 and maintaining the highest possible financial audit levels attainable. These administrative management performance goals listed below will help FDA provide more effective and efficient services to the public and regulated industry but will help the Programs accomplish their performance.

B. Summary of Performance Goals

*This goal refers to the percentage of purchases that are eligible to be purchased electronically. Not all FDA purchases are eligible to be purchased electronically.

C. Goal-By-Goal Presentation of Performance

1. Increase supervisory ratio to increase span of control among management personnel. (19001)

• Context of Goal: FDA is making significant efforts to de-layer the agency further and allow for a more effective structure and a streamlined organization, as well as increase the span of control for managers across the Agency. FDA is a knowledge-based organization, which utilizes complex scientific systems and overseas research activities, which complicate increasing the span of control too much. 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.
• Data Sources: FDA Personnel databases
• Performance: The FY 2000 supervisory ratio was 1: 7.31 Agency wide. This is a slight decrease from FY 1999, due to critical managerial hiring needs in the scientific components in the Agency. In FY 2001 the Agency exceeded the goal of 1:7.28 because of consolidation within the field force.

2. Consolidate administrative functions in the Agency. (19002)

• Context of Goal: FDA is aligning itself with Departmental guidelines for the consolidation of administrative 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 administrative 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. These are listed below.

FY 2003

Consolidate the following administrative management functions:

• Personnel
• Finance
• Budget
• Procurement
• Grants
• Information Technology
• Legislative Affairs
• Public Affairs

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

FY 2000

• Abolished the Office of External Affairs.
• Eliminated two Deputy Commissioner positions
• Eliminated the Office of Industry, Small Business and Constituent Affairs Staff
• Eliminated the Office of Health Affairs

FY 1999

• Consolidated 10 OC offices in External Affairs across four allowances to fall under one allowance. Consolidated the budget process for these offices to allow for greater efficiencies.
  • Data Sources: FY 2001 FDA Workforce Restructuring Plan
  • Performance: 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 will have met its FY 2003 schedule of elimination of all targeted positions except the Principal Deputy Commissioner, as the Deputy Commissioner for International and Constituent Relations plans to retire in September 2001. FDA is currently taking steps to consolidate the personnel, information technology, budget, finance, procurement, grants, legislative affairs and public affairs functions within the Agency by FY 2003.

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

• Context of Goal: FDA has outsourced many of its functions to the commercial sector and will review the Percentage of Commercial FTE for these years for additional possible outsourcing. In FY 2002, FDA has committed to review the following functions: graphic design, library and web design development. In each of FY 2003, FY 2004 and FY 2005, FDA will review an additional 10 percent of the Agency's Commercial FTE for possible outsourcing. In FY 2006, FDA plans to review an additional 15 percent of its Commercial FTE for possible outsourcing. This brings the total Commercial FTE FDA will review for outsourcing by FY 2006 to 50 percent.
• Data Sources: FY 2001 FDA FAIR Act Inventory
• Performance: For the past few years, FDA has been converting many of its activities to be commercially outsourced. In particular, FDA has outsourced animal husbandry services, building operations and maintenance, mail service and certain IT activities. FDA is committed to reviewing the above listed additional Commercial FTE for possible outsourcing in the out-years.

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. The definitions for the FY 2000 Actuals and the Targets for FY 2001, FY 2002, and FY 2003 are the same.
• Data Sources: FDA Small Purchase System, statements from bank card company
• Performance: Ninety four percent of eligible transactions were purchased electronically in FY 2000. FDA expects this figure to grow and also expects to significantly exceed the departmental targets given to FDA. The Agency is conscientiously seeking to use the Impact Card instead of a purchase order for buying items with low overhead costs. By using the Impact Card, the Agency lowers the $90.00 overhead cost for each purchase. This then has led to the Agency exceeding its goal for FY 2001 as expected.

5. Maintain a clean (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 timely. Since then, FDA has managed to progressively perform at a higher level.

• Data Sources: Fiscal Year 2000 FDA Chief Financial Officer's Annual Report.
• Performance: FY 2000 Performance is at 100 percent. Since FY 1997, the performance has steadily improved due to FDA taking many corrective actions, including establishing a branch organization 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 2000. 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 in the implementation and development of 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 UFMS will lead to improvements.

6. Increase percentage of contract dollars to performance based contracts from 30 percent.

• Context of Goal: This goal is based on three key policy decisions to enhance performance-based contracts. First, Policy Letter 91-2 commits the Federal Government Policy to use performance-based contracting to the maximum extent practical when acquiring services. This was followed by a March 9, 2001 memorandum OMB's Deputy Director directing agencies to use performance-based technique in at least 20 percent of all service contracts worth more than $25,000 in FY 2002. Finally, on June 14, 2001 Secretary Tommy Thompson directed all OPDIVs to submit implementation plans for achieving OMB's goal of awarding 20 percent of eligible contract dollars using PBC by FY 2002.
• 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.
• Performance: 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.

7. Assure continuity of FDA operations in case of an emergency.

• Context of Goal: In light of the September 11, 2001 events, the Agency decided to develop a Continuity of Operations Plan (COOP) to allow it to keep its major programs functioning in the event of a disabling attack. Executive Order 12656, Presidential Decision Directive 67 and Federal Preparedness Circular 65 reinforced this objective.
• Data Sources: Success will be measured based upon awarding the contract during FY 2002.
• Performance: N/A

8. Enhance the Agency Emergency Preparedness plan to establish protocols for responding to terrorist attacks.

• Context of Goal: The events of September 11, 2001 and subsequent incidents involving anthrax contamination raise the frightening prospect that FDA-regulated products could be used as vehicles to cause widespread harm to U.S. citizens. FDA's Counter Terrorism Plan outlines a strategic blueprint for protecting U.S. citizens in the event of future terrorist attacks. One of the key goals of the Plan is to sharpen the Agency's emergency preparedness and response capability so that FDA is poised to protect the Nation and itself in the event of an attack. 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.
• Data Sources: Development of protocols for responding to terrorist attacks.
• Performance: N/A

2.1.3 Verification and Validation

FDA will ensure consistency in the tracking and reporting of the administrative management performance goals. In addition, FDA is taking steps to routinely monitor this data and take appropriate actions as needed. Data is from a variety of sources for these performance goals including the Annual Chief Financial Officer's Report, Civilian and Commission Corps personnel databases, monthly and annual full-time equivalent (FTE) reports and data-runs, the FDA FAIR Act Inventory and the FY 2001 FDA Workforce Restructuring Plan, monthly statements from bank card companies and the FDA Small Purchase System.

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

Previous Section    |   Table of Contents    |   Next Section

Office of Planning Home Page
FDA Home Page | Search | A-Z Index | Site Map | Contact FDA

FDA/Office of Planning
Web page created by clb 2002-FEB-11.