DEPARTMENT
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For more information about this report, contact: Office of Planning and Evaluation U.S. Food and Drug Administration 5600 Fishers Lane, Rockville, MD 20857 Phone: (301) 827-5206, (301) 827-5208, or (301) 827-5226 |
Part I: | Overview
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Part II: | Budget and Program Summaries |
Note on printing the plan: This document is divided into several sections. Each can be printed separately. The entire text of Part I, Introduction to Budget and Program Summaries, and the FY 1999 Program Resource Summary can be printed together. To print the program summaries, navigate to each section and then print. (Tobacco, Imports, and External Leverage are combined in one file.)
The uses of the FY 1999 Performance Plan are many. For example:
The FDA Mission Statement, from Public Law (PL) 105-115. Linkage to the Mission and Strategic Plan of DHHS. The four Key Performance Commitments indicate that food safety, drug and medical device approval, tobacco use among youth, and partnerships for health protection will be some of FDA's most important outcome-oriented goals for FY 1999. The Programs indicate how FDA's resources are organized. The Strategic Framework summarizes the overall structure and strategies for conduct of the Plan. It focuses all Agency programs on results-oriented goals described by GPRA.[1]
The Measuring, Monitoring and Reporting on Results pages discuss the task of FDA's verifying and validating the goals -- and monitoring how well they are being accomplished. |
The Introduction to Part II indicates how the FDA program narratives are arranged within FDA's Performance Plan. Program Goal Summaries: The last section of the Performance Plan is arranged by FDA program area, and provide information about each program's proposed goals for FY 1999 that includes: | |
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1. FDA's FY 1999 Performance Plan is part of a government-wide effort to hold agencies accountable for achieving results. In 1993, with passage of the Government Performance and Results Act (GPRA), Congress directed all Federal agencies to adopt more businesslike management approaches. This reflected a new commitment to reducing costs and improving performance. FDA's 1999 Performance Plan represents an important step toward enhancing its record of public health improvement, while at the same time providing a cost-effective value for American taxpayers.
Food and Drug Administration
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"To enhance the well-being and health of Americans by providing for effective health and human services and by fostering strong, sustained advances in the sciences underlying medicine, public health and social services."
The FDA plan also puts into action the goals and objectives set forth by the DHHS strategic plan. FDA is committed to the following five strategic objectives that are included in the DHHS plan:
Outcome: | Reduce illness associated with microbial contamination of foods. |
Background and Strategy: |
Although the U.S. food supply is one of the safest in the world, the increasing number of reported foodborne illnesses threaten public health. Available estimates of foodborne illnesses run into the millions, with thousands of deaths every year. Causes of these illnesses range from a lack of knowledge about safe food handling practices, to physiological changes in microorganisms, to changes in the food supply and its distribution, to an increasing number of consumers vulnerable to foodborne illnesses because of their compromised health status. Some previously harmless microbes are now causing diseases, and some are even developing resistance to traditional medical treatments or to techniques used to prevent their growth in food.
As part of the interagency Food Safety Initiatives, FDA is working with USDA, CDC, EPA, international groups, states, consumers, academia and industry to improve the safety of the food supply. Key components of this integrated effort include targeting the most pressing microbial public health hazards; quickly identifying foodborne illness outbreaks; improving food inspections; and educating consumers, industry, and health professionals. This initiative will also emphasize surveillance for foodborne illness, risk assessment, research, and improved coordination and communication to rapidly deal with emerging public health hazards.
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Key FY 1999 Performance Goals: |
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Outcomes: |
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Background and Strategy: |
FDA has the responsibility to assure that all drugs used in the prevention, diagnosis and treatment of disease are safe, effective and properly labeled. In order to do this, important new drugs must reach the American public as quickly as possible. Last year, approximately 11 million Americans received newly marketed drugs that would not have been available until 1998 without passage of the Prescription Drug User Fee Act that expanded FDA's capacity to speed the review process.
In order to bring important drugs, medical devices, and food additives to market quickly and safely, FDA will commit to: increasing the number of early consultations with product manufacturers; upgrading communications technologies that will expedite new product applications; and accelerating the review of products that will improve Americans' health. Harmonizing this overall effort with international drug, medical device, and food additive manufacturers has also become an important strategy for improving product safety. Through earlier and more cooperative interaction with FDA, industry representatives have indicated the possibility of a year reduction in the time necessary to bring drugs to the market. |
Key FY 1999 Performance Goals: |
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Outcome: | Substantially reduce youth smoking. |
Background and Strategy: |
Each day approximately 3,000 young people become regular smokers. In fact, 34 percent of high school students smoke cigarettes. The cost of direct medical care for tobacco-related illness is estimated at $50 billion a year. Research shows that reducing the rate of tobacco use will improve the health and quality of life across America. FDA now has authority to regulate the use of cigarettes and smokeless tobacco as delivery devices for the drug nicotine.
In cooperation with the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA), FDA has committed to controlling tobacco use. In support of the goal of reducing youth smoking by 50 percent by the year 2003, FDA will implement and oversee enforcement of the regulation that restricts access and marketing of tobacco products to minors. With its public and private partners, FDA will educate, monitor, and enforce several strategies to achieve this outcome.
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Key FY 1999 Performance Goals: |
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Outcome: | Launch a more effective national response to public health risks through partnerships and shared responsibilities.
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Background and Strategy: |
Americans are among the healthiest people in the world. But we do not live in isolation. Each neighborhood, town, city, and region is affected every day by movement of people, products, and ideas that may have originated anywhere in the world. As a result, FDA is changing how it will protect consumers and promote the public health in the 21st Century.
In FY 1999, FDA will collaborate with and rely on outside parties for the management of health and safety risks to a much greater extent than ever before. FDA will use its regulatory partners, health care delivery institutions, the regulated industry, and the consumer as "multipliers" of risk management. The performance goals outlined below for FY 1999 demonstrate how the Agency is making strides in collaborative health protection by working closely with consumers, states, other Federal agencies, and international organizations.
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Key FY 1999 Performance Goals: |
With consumers' help, increase public understanding of food and drug labeling.
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FDA resources are organized into seven "programs" that coincide with the organization of the President's annual budget. These programs constitute the major sections of the performance plan. Each program has some responsibility for one or more performance commitments.
Foods - The mission of the Foods program is to promote and protect the public health and economic interest by ensuring that the food supply is safe, nutritious, wholesome, and honestly labeled. The national Food Safety Initiative is FDA's newest collaborative program. The program also ensures that cosmetics are safe and properly labeled.
Human Drugs - The mission of the Human Drugs program is to ensure 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. FDA will work more closely with drug firms to foster industry-based quality assurance programs and raise the pledge (assurance) of safety.
Biologics - The mission of the Biologics program is to ensure 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, bacterial vaccines and antigens, viral vaccines, therapeutic agents, and other biological products.
Medical Devices and Radiological Health - The mission of the Medical Device and Radiological Health program is to ensure that medical devices intended for human use are safe, effective, and properly labeled; and that the public is not exposed to unnecessary radiation from medical, industrial, and consumer products. FDA will concentrate resources on high-risk, high-impact products or work areas, where direct intervention helps consumers and health professionals the most.
Animal Drugs and Feeds - The mission of the Animal Drugs and Feeds program is to ensure that only safe and effective animal drugs, devices, feeds, and food additives are marketed; and ensure that foods and food additives from animals that are administered drugs, in accordance with label directions, are safe for human consumption.
National Center for Toxicological Research - The mission of the National Center for Toxicological Research (NCTR) is to implement peer reviewed, high-quality scientific research to develop methods for regulatory applications and provide a mechanistic basis for human risk assessment as it pertains to FDA's regulatory mandate. NCTR accomplishes its mission by conducting fundamental and applied research.
Tobacco - The mission of the Tobacco program is to reduce young people's use of tobacco by the year 2003 through education, enforcement, and partnerships with the Centers for Disease Control and Prevention (CDC), and other Federal and state health agencies.
Two features of this framework are important to notice. First, the four goal areas shown across the two top rows overlap with the four performance commitments that FDA has made in the FY 1999 Performance Plan. This has helped to validate the Agency's highest priorities. Second, the framework emphasizes performance improvement and risk management. For example, FDA would focus first on regulatory actions that have the potential to impact the most Americans.
Goal Area | REVIEW |
ASSURANCE |
CAPACITY |
LEVERAGE |
Goal Statement |
Make timely and cost effective premarket review decisions while assuring product safety and efficacy | Strengthen assurance that products on the market or about to enter the market are safe | Focus FDA's capacity for effective pre and postmarket regulatory decisions | Augment the ability of external stakeholders to manage FDA-regulated risk |
FDA Strategies |
Develop science-based review standards Inform and assist product sponsors Streamline reviews Focus on high priority applications Increase patient access to experimental therapies. |
Develop science-based product and process standards and guidance Target high priority domestic and import risks Inform and assist firms to achieve conformance Maintain inspection visibility Improve surveillance and follow-up on adverse events Integrate import and international harmonization activities |
Implement decision-supportive information systems Cultivate a high quality, motivated workforce Achieve greater economies in facilities Refocus FDA's pre and postmarket responsibilities Consolidate and prioritize research activities Increase coordination of international harmonization activities |
Foster industry quality assurance programs, e.g. HACCP Support U.S. interests in global standard setting Empower consumer choice through product labeling and education Use third parties for routine reviews and compliance monitoring Collaborate with Federal and state regulators to reduce health risks Collaborate with industry in support of research Pursue public-private partnerships to expand resources |
This approach will be used both to improve program performance within the Agency and to keep the Executive Branch and Congress informed on FDA's achievements, as required by the Government Performance and Results Act (GPRA). The Figure below illustrates the process.
Challenges in Measuring Performance:
Measuring the status of each goal will become the most critical step to knowing how well the Agency is achieving its mission. As evident from the Strategic Framework and the diverse goals included in this plan, FDA will be relying on an array of different measures to determine the organization's overall performance.
While FDA is a regulatory agency that must enforce laws and monitor compliance with the laws, the Agency has dramatically changed how it exercises this responsibility. Growing emphasis is placed on assisting the regulated industries to meet public health and safety requirements. And this changes how FDA approaches performance measurement. On the surface, some goals may appear less challenging compared with past (baseline) performance. In reality, these goals reflect a strategic advancement by focusing on higher-risk, higher-impact responsibilities that will make the Agency more responsive to the future.
With greater emphasis on outcomes, and with the establishment of more external partnerships to achieve those outcomes, agencies will depend on one another to generate useful outcome measures. Of the database examples below, the majority are not exclusively used by FDA to measure performance. Rather, they demonstrate a shift toward true results that can only be accomplished in conjunction with other institutions sharing the same public health interests.
The FDA Approach:
In 1998, FDA will initiate a system to help program managers to verify and validate performance measures. This system will have three basic components: (1) training workshops for program managers to learn the essential aspects of performance measurement; (2) a comprehensive checklist for verifying and validating performance information used to establish and monitor progress toward each goal; and (3) assistance in applying performance data as an effective management and reporting tool. This process will progressively enhance the Agency's ability to achieve and measure meaningful results.
Current Performance Measurement Efforts:
For every goal in the Performance Plan, FDA indicates what databases and baseline measures are available (or under development) to assess the goals. The Agency will use a combination of existing and newly designed databases to assess progress in achieving its goals. Many databases are collaborative efforts between other Federal and state agencies, consumer and industry groups. Some are exclusive to FDA.
The following few examples illustrate FDA's use of diverse data sources to verify and validate performance. Each of these examples relate to at least one of FDA's performance goals.
Examples of Measurement Systems:
Tobacco |
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Premarket |
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Partnerships |
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Food Safety |
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Through effective database management, FDA will gain important information needed to monitor progress and develop realistic future goals. As appropriate, these goals and the strategies for achieving them may be modified based on performance data.
FY 1999 Resources: This shows the anticipated costs and number of full-time employees (FTE) needed to accomplish the program's responsibilities.
Strategic Future: This short narrative offers readers important facts or insights into emerging issues, opportunities, or threats related to accomplishing program goals.
Clusters: FDA's programs found it helpful to combine the most closely related performance goals into several "clusters." Within most clusters you will find:
Performance Goals: The detailed performance goals also include supplementary information, written in a way meaningful to program managers. That information includes:
Performance Measurement: FDA has developed guidelines to verify and validate its FY 1999 performance goals. These guidelines go beyond the steps of finding and generating data related to each goal, to "knowing" that the measurement approach to each goal is valid and helpful in deciding how well the goal is being accomplished. From year-to-year this process of verifying and validating performance goals will lead to even better, more realistic outcome-oriented performance goals. As appropriate, each FDA program comments on their performance measurement strategy.
Program/Cluster | $000 | FTEs |
Food and Color Additive Review | 18,380 | 200 |
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Food Safety Assurance | 166,078 | 1,623 |
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Internal Capacity Building | 37,420 | 342 |
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Coordination | 26,839 | 278 |
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Program Total | 248,717 | 2,443 |
HUMAN DRUGS
Premarket Review | 197,984 | 1,533 |
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Postmarket Assurance | 12,145 | 547 |
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Internal Capacity | 66,646 | 404 |
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External Leverage | 13,088 | 171 |
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Program Total | 289,863 | 2,655 |
BIOLOGICS
Prescription Drug User Fee Act | 64,608 | 493 |
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Blood and Blood Components | 35,587 | 424 |
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Biologics Compliance | 24,233 | 159 |
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Program Total | 124,428 | 1,076 |
ANIMAL DRUGS AND FEEDS
New Animal Drug Review | 18,906 | 186 |
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Postmarket Assurance | 26,068 | 257 |
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Program Total | 44,974 | 443 |
MEDICAL DEVICES AND RADIOLOGICAL HEALTH
Premarket Review | 55,035 | 620 |
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Science, Technology and Standards | 10,890 | 121 |
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Postmarket Assurance | 14,590 | 163 |
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Compliance | 38,152 | 416 |
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Mammography Quality Standards Act | 24,580 | 111 |
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Radiation Control for Health and Safety Act | 12,707 | 139 |
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Program Total | 155,955 | 1,569 |
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
Build Knowledge Bases | 4,593 | 15 |
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Develop New Stratgies for the Prediction of Toxicities | 10,222 | 82 |
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Methods-, Agent-, Concept-Driven Research | 16,764 | 128 |
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Program Total | 31,579 | 225 |
TOBACCO
Tobacco | 134,000 | 50 |
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Program Total | 134,000 | 50 |
Resource amounts are based on FY 1999 Request and include resources for Budget Authority and User Fees (i.e., PDUFA, MQSA and Exports).