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DEPARTMENT |
Welcome to the Food and Drug Administation's FY 2000 Annual Performance Plan
Part One: FDA's Strategic Framework for the 21st Century
Part Two: FDA's FY 2000 Performance Goals
Appendices:
This U.S. Food and Drug Administration (FDA) Agency Performance Plan is organized into two components:
Part One outlines FDA's strategic framework that will position the Agency to meet the scientific and regulatory demands of the 21st Century. The framework consists of:
Part One also includes the FY 2000 goals that FDA has identified in its role as an NPR-designated High Impact Agency.
Part Two includes both the revised final FY 1999 Performance Plan, based on final appropriations, and the FY 2000 Performance Plan.
The revised final FY 1999 Performance Plan appears as a final list of the Agency's FY 1999 performance commitments, and a summary of changes to the previously published FY 1999 goals. This information is found in Appendices 1 and 2.
The FY 2000 Performance Plan includes performance goals for FY 2000, the approaches that will be used to pursue them, and the total resources required to achieve these goals. The performance goals are grouped by FDA's programs: Foods, Human Drugs, Biologics, Medical Devices and Radiological Health, Animal Drugs and Feeds, the National Center for Toxicological Research, and Tobacco. These organizational components will be responsible for implementing the plan and achieving the goals.
PART ONE: FDA'S STRATEGIC FRAMEWORK
FOR THE 21ST CENTURY
As a second key component of its strategic framework, FDA leadership has conducted an assessment of both its external and internal environments in order to identify the challenges the Agency will be facing over the next several years. This has included delineation of FDA's statutory requirements and public expectations, evaluation of environmental factors that will affect the Agency's future actions, and a review of current program performance. As a result of this assessment, leaders have identified the broad dimensions of a gap between what FDA is required and expected to accomplish and what it is currently able to achieve. During the summer of 1998, FDA leaders discussed this gap with many of its external stakeholders and received several constructive suggestions on possible future courses of action.
Based on its own assessment and the recommendations of stakeholders, FDA has formulated a plan to narrow the gap between expected and actual performance. This plan includes broad strategic initiatives that will be pursued over the next several years, Agency-wide approaches that will be implemented to strengthen all initiatives, and annual performance plans for FY 1999 and 2000 that translate these broad initiatives into specific performance commitments. FDA, with the help of its stakeholders, will continually evaluate the effectiveness of its strategic initiatives and performance goals, and will report on its progress to Congress and other stakeholder groups. Figure 1 outlines the strategic management process that FDA implemented in developing the strategic and performance components of the Agency Performance Plan.
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With the passage of the FDA Modernization Act of 1997 (FDAMA), Congress enhanced FDA's mission in ways that recognized the Agency would be operating in a 21st century characterized by increasing technology, trade, and complexities in public health protection. To meet these challenges,Congress added explicit phrasing to the Agency's mission statement to ensure that FDA would coordinate its efforts with regulatory counterparts worldwide. In addition, Congress recognized that scientists both within and outside the Agency play critical roles in carrying out FDA's responsibilities. Finally, Congress placed new emphasis on the need for FDA to interact on a regular and meaningful basis with its stakeholders.
Statutory Mandates
A myriad of statutory requirements translate FDA's broad mission into specific performance expectations. Two statutory categories that are central to the Agency's mission are specified time frames for review of new drug, medical device and food additive applications and frequency of inspections of drug, biologics and medical device establishments. Section 406(b) of FDAMA directed FDA to develop a plan for meeting these and other statutory requirements. The FDA Plan for Statutory Compliance was completed in November and submitted to Congress. It includes a complete listing of the Agency's statutory requirements, and is available at the following Internet address: http://www.fda.gov/opacom/7modact.html.
Emerging Environmental Challenges
FDA must address a wide range of challenges that serve as potential obstacles to successfully carrying out its health protection mission and meeting its key statutory mandates.
The Gap Between Expectations and Actual Performance
The environmental challenges discussed above are significant because they essentially define the nature and size of the workload that FDA will have to address in the future. To the extent that these factors can be correctly anticipated, the Agency can estimate the gap between expected and actual performance. But these estimates will change because the forces themselves are dynamic. No one knows with precision what the level of industry research and development will be even next year; medical breakthroughs cannot be scheduled, and most health or safety crises cannot be predicted. For example, it is difficult to use a durable set of cost figures to determine the level of resources that will be required to review next year's submissions of new drug applications.
However, the Agency can assert that the convergence of complex environmental challenges and sharp federal budget constraints has prevented FDA from fully meeting its explicit statutory obligations. A sizable gap still exists between statutory time requirements and actual performance for application review in several product areas (Figure 2). There is a similar gap between mandated and actual inspectional coverage for FDA-regulated industries. (Figure 3). Additional gaps exist between public expectations and current federal capability. The U.S. public expects and deserves a coordinated food safety assurance system, but one is not presently in place. In addition, the Agency has not yet initiated a comprehensive system of surveillance that can monitor, detect and correct adverse experiences associated with use of FDA-regulated products. Finally, our nation's youth continue to use tobacco without an adequate monitoring system in place to prevent illegal sales of tobacco to this segment of the population. The FY 2000 budget increases will help to narrow many of these gaps, but they will not be completely eliminated with these resources alone.
Stakeholder Consultation
FDA solicited the viewpoints of its stakeholders in a series of public meetings during the summer of 1997, and through public dockets and electronic communication. Stakeholders were asked to give their views on FDA's key priorities, and the strategies that would be most effective in closing the gap between what FDA was required and expected to do, and what it is currently able to accomplish. Since FDA's many stakeholder groups are a heterogenous population with diverse interests, their collective viewpoints did not converge on a definitive list of programmatic priorities. Two general themes, however, did emerge:
The above two themes provide the Agency with important signals on the kinds of Agency-wide approaches to which stakeholders would be receptive, and which would constitute critical elements of any specific initiative undertaken in the future. The process of engaging the Agency's stakeholders and receiving useful feedback is an ongoing one. The Agency's various constituencies will continue to play an integral role both in the formulation of specific risk management strategies, and in broad strategic assessment of FDA's overall directions.
Strategic Initiatives/Agency-wide Approaches
Through the assessment described above, FDA has formulated five strategic initiatives, each of which addresses a critical public health or safety challenge that affects major segments of the U.S. population. Successful pursuit of these initiatives will produce results that effectively close the gap between expectations and the current reality. FDA will implement these initiatives by applying approaches that collectively represent FDA's corporate philosophy. They describe how the Agency intends to operate in order to satisfy its mission and be responsive to the expressed needs of its stakeholders. Figure 4 illustrates how these approaches will be key to the Agency's successful accomplishment of each initiative.
The following two sections describe these Agency-wide approaches and give an overview of each of FDA's five strategic initiatives.
Agency-wide Approaches
Establish Risk-Based Priorities: FDA must decide, based on continuing consultation with its stakeholders, which health and safety risks most directly threaten the well- being of U.S. consumers, and allocate its resources accordingly. Given limited resources, FDA simply cannot meet everyone's demands, and cannot address all risks with the same degree of urgency or intensity. For example, the Agency is unable to respond to its highest priority health risks and at the same time fully meet its biennial statutory inspection requirements. The Agency has and will continue to increase the efficiency of "fast track" processes so that the most urgently needed therapies can enter the marketplace rapidly. Surveillance and compliance efforts will also continue to be directed toward the most serious health and safety problems.
Strengthen the Scientific and Analytical Basis for Regulatory Decisions: A strong science base underpins each of the Agency's regulatory decisions, from initial research, development and testing, through production, marketing and consumption of regulated products. A strong science base consists of the necessary professional expertise, risk assessment protocols, test methods, product guidance, performance standards, and the facilities and equipment necessary for conducting excellent science. FDA continues to improve its scientific capabilities through access to and collaborative efforts with sources of scientific expertise beyond FDA.
Work More Closely With External Stakeholders: FDA will need to leverage its own capability to address complex public health problems by working with external stakeholders. Solutions to health risks do not lie solely in expanding the size of the Agency. Consumers, the regulated industry, health professionals, and FDA's regulatory counterparts in the U.S. and abroad each represent components of a total network that can potentially improve health outcomes. Cooperation with the Agency's stakeholders will be well informed by establishing and maintaining vehicles which promote continuous dialogue between FDA and its constituencies.
Re-engineer FDA Processes Where Appropriate: This principle is based on the assumption that for organizations to survive and thrive in turbulent environments, they must not be satisfied with "programmed" approaches to problem solving. FDA has redesigned many of its regulatory review processes to improve internal efficiencies. The Agency is also implementing several protocols that will result in simplified regulatory approaches, and as a result, will reduce the burden for the regulated industry.
Adopt a Systems Rather than a Piecemeal Approach to Agency Regulation: The Agency will continue to develop a systemic understanding of health and safety problems and the possible solutions to those problems. This entails an ability to explain relationships among variables in the system, to identify critical variables that drive the effectiveness of a total system, and then to direct resources more effectively to maintain those critical variables within acceptable limits. A prime example of capitalizing on systemic understanding is the implementation of the HACCP concept in food industries.
Capitalize on Information Technology: FDA has been able to take advantage of rapidly evolving information technologies to improve internal efficiencies. For example, automating major portions of the drug review process has accelerated the review of new drug therapies. More recently, the Agency has turned its attention to using information technology as a way of improving communication with external stakeholders. One of the most powerful examples of how stakeholders are assisted is in the rapid provision of information on new drug therapies to consumers and patients via the Internet.
FDA Strategic Initiatives
The Agency intends to address its mission, mandates, environmental challenges and stakeholder expectations with five strategic initiatives that will be pursued in FY 2000 and beyond.
The premarket application review initiative addresses the proliferation of, and need for, high technology products. The Agency will continue to work closely with industry to bring new products with great health benefits to the market rapidly while ensuring their safety and efficacy.
Three initiatives--product safety assurance, food safety, and injury reporting--contribute to building a broad safety net that maintains high public confidence in all FDA-regulated products. FDA will collaborate with many public and private stakeholders in monitoring all phases of production and distribution, from product research and development through production, distribution and consumption. The net must have a strong science foundation and enlightened product and process standards. It must also have the ability to manage emerging risks through education, technical assistance and enforcement actions as necessary.
These three initiatives will make the following contributions:
The fifth initiative, regulating Tobacco, targets a pervasive, high-risk area that threatens the health of a large portion of the U.S. population. FDA has identified the reduction of tobacco use by the youth of this nation as a major strategic focus. The Agency will work closely with states and other stakeholders to reduce young people's access to tobacco and lessen the appeal of tobacco products.
A full explanation of the five initiatives follows, including a description of the challenge posed by the environment and FDA's plan to meet the challenge and measure its success.
Premarket Application Review
Intended Outcome: Reduce the time required to make important new human drugs, veterinary drugs, blood products, medical devices, vaccines and food additives available to the U.S. public.
Background: The nation's (and world's) research and development community continues to proliferate many new, and often technologically complex, products with health-giving properties. FDA will continue to facilitate their availability. FDA is also required by the Food, Drug and Cosmetic Act to review new product applications within specific time frames. The need to meet these time frames has been reinforced by the recent FDA Modernization Act of 1997.
FDA continues to make significant strides in accelerating approvals of new drugs and biological products. In 1998 the Agency approved 90 original new drugs, with a median approvaltime of 12 months. Of these approvals, 25 were for priority products considered to be of exceptional public health value. The priority products were approved in a median time of 6.4 months.
The Agency has made these product review improvements under commitments made in association with the Prescription Drug User Fee Act. However, the Agency has not been able to meet statutory time frames in other key product areas.
FDA's Plan: FDA will focus its efforts on accelerating reviews in the product areas that are not currently meeting the premarket review time frames defined by law and by the expectations of FDA's stakeholders. These areas include: medical devices, blood products, generic human drugs, veterinary drugs and food and color additives. Several interlocking strategies will be used to meet these review goals. First, the Agency will dedicate additional reviewers to these high-priority areas. To ensure wise use of reviewers' time, the FDA has re-engineered its product review processes in many areas, and will continue to look for more effective means of shortening processes without sacrificing quality and safety concerns. Second, several initiatives are underway to reduce the direct review burden on the Agency by reducing the requirement for pre-approval in some areas and replacing it with an industry notification process. Third, consultation with product sponsors early in their research and development process will raise the likelihood that high quality commercial applications will follow, and make their way through the FDA system in the shortest time possible. Finally, all of FDA's product review centers will continue to automate their application submission and review tracking systems. This should result in not only faster review times, but also increases in Agency productivity.
How performance will be measured: For programs in which information systems are mature, performance will be measured by faster review times. For programs which are being re-engineered and/or new regulatory approaches are being used, performance will be gauged by milestones which mark the implementation of new information systems, regulatory approaches, and management mechanisms.
Product Safety Assurance
Intended Outcome: Assure that FDA-regulated products are being produced and marketed under conditions that will assure their safety, quality and efficacy.
Background: FDA's ability to guarantee the quality and safety of all regulated products from domestic and foreign sources is declining. The Agency, even with the help of its state partners, and with projected resource increases in FY 2000, is falling considerably short of conducting the biennial inspections of drug and medical device firms required by law. The average food plant is inspected less than twice a decade, a frequency far below public expectations. Although the Agency reviews nearly four million import shipments of regulated products each year, it directly examines only a very small percentage of these entries. In addition, import entries continue to grow in number, complexity, and in diversity of sources. To illustrate, in 1997 over $10 billion in pharmaceuticals and medical devices were imported into the United States from the European Union (EU). By the year 2000, FDA may be equipped to handle less than one inspection per $100 million in EU pharmaceutical exports. The Agency needs a way to verify the safety of imports from point of origin through point of entry.
FDA's Plan: FDA intends to meet its domestic statutory requirement by inspecting domestic firms more often with the assistance of our state regulatory counterparts. The Agency will also use multiple strategies of education, technical assistance, targeting higher risk industry sectors, and enforcement (when necessary) to correct product risk in the market place. A key element of assuring quality and safety, particularly in the food industry, will be to strengthen the ability of industry to develop its own safety and quality monitoring systems. This will be accomplished by expanding the Hazard Analysis and Critical Control Point (HACCP) program from seafood to other industry segments. To improve monitoring of imports, FDA will continue to cooperate with the U.S. Customs Service and build on the early successes of our electronic import entry system. Currently, more than half of FDA's import categories are electronically screened based on historical data, and allowed entry to the U.S. within 15 minutes. The enhanced entry system will also provide the Agency with national "electronic profiles" of high-risk imports, which can then be more effectively targeted through a selected sampling program. While improving import safety at the border, FDA will also be strengthening surveillance at the source of production. Finally, the Agency will continue to work on international preventive strategies through participation in international standard setting and mutual recognition of safety assurance.
How performance will be measured: For domestic industries, performance will be measured by the increasing portion of the industry that will be covered by inspections, and by the rate of conformance to FDA regulations. Industry's ability to self-monitor will be measured by the percentage of firms in a target sector that have successfully installed these systems. For the import sector, effectiveness in allowing safe products to enter the country will be measured primarily by the percentage of products for which FDA can make rapid and reliable entry decisions.
Food Safety
Intended Outcome: Increase consumer confidence in the safety of the nation's food supply.
Background: In 1997 the United States Department of Agriculture (USDA) recalled 25 million pounds of raw hamburger because of possible E. coli bacterial contamination, which can cause serious illness, and even deaths. And when health officials linked a 1998 hepatitis outbreak in Michigan to frozen strawberries from Mexico, more questions arose about the source of foods on American tables. Some 40 percent of fruits and vegetables in the United States are grown outside our borders. Although overall mortality and morbidity rates resulting from foodborne contaminants are not known with precision, even the anecdotal evidence of food-related illness is sufficient to be disquieting.
At the President's urging, several federal and state agencies are collaborating in a multi-sector initiative to strengthen the nation's food safety status. This initiative combines surveillance, compliance, research, risk assessment and education. Thus, the Food Safety Initiative contains all of the elements necessary to weave an impressive safety net in which FDA plays a central role. The Agency is home to expert food scientists, and a substantial portion of the field force is dedicated to the assurance of food safety in domestic firms. However, for a truly collaborative inter-agency, inter-sector system to work effectively, time will be required to coordinate various research protocols, standards, information systems and other institutional arrangements.
FDA's Plan: There are two key elements in FDA's Food Safety Initiative. First, the Agency will expand its research, risk assessment, surveillance, compliance, and educational capabilities and focus this expertise on the highest priority food safety risks. Second, FDA will strengthen its capability to work collaboratively with Department of Agriculture (USDA), the Centers for Disease Control and Prevention (CDC), the Environmental Protection Agency (EPA), the states, and the regulated industry. This will require the development of risk assessment priorities, risk management strategies, and information systems that are compatible with those of the Agency's partners. This coordination is essential so that food safety problems can be addressed quickly and effectively.
How Performance Will Be Measured: Progress in the Food Safety Initiative will be measured primarily by milestones which demonstrate that critical components of the food safety net are being put into place. One of those critical elements is a food safety surveillance system that will track the health and safety outcomes of this initiative.
Injury Reporting
Intended Outcome: Reduce injuries and illnesses resulting from consumption and use of FDA-regulated products.
Background: A 1998 study published in the Journal of the American Medical Association (JAMA) estimates that nearly 7 percent of hospitalized patients suffer a serious or fatal reaction to drugs administered during their hospital stay. This would make such adverse reactions to prescription drugs the fourth leading cause of death in America, behind heart disease, cancer, and stroke.
There is no comprehensive surveillance system in place to accurately identify the number of adverse events that are associated with use or consumption of FDA-regulated products, to evaluate the cause of these incidents, or to formulate the strategies needed to avoid similar future incidents. Existing passive reporting systems are not adequate to gauge the scope of these problems. Consequently, neither FDA nor its health and regulatory partners have precise data on the magnitude of the adverse event problem. However, several reporting systems exist, both within FDA and in other organizations. The challenge is to determine which elements of existing systems can be capitalized upon, and what new aspects will be needed for a comprehensive system.
FDA's Plan: FDA is currently determining which elements of a comprehensive reporting and intervention system can be centralized and which should remain tailored to the needs of our respective product centers. In the process of reaching out to its partners in this area, the Agency will capitalize on existing collection and reporting systems. FDA will also build a surveillance system that will use representative samples to collect information based on epidemiological data and known relative risks. The overall strategy combines elements of surveillance, problem analysis, education and problem correction through elimination of the conditions that led to the high-risk situation.
How Performance Will Be Measured: Performance will be monitored by the milestones that mark implementation of a comprehensive adverse event reporting and intervention system. As in the case of food safety, once the key elements of this system are in place, it should provide the Agency with a future capability to track health and safety outcomes that result from Agency strategies.
Tobacco
Intended Outcome: Reduce the incidence of tobacco use by the youth of our nation.
Background: Every day about 3,000 young people begin smoking, and it is estimated that 1,000 of them will die prematurely. In fact, 34 percent of high school students know the dangers and still smoke. Americans pay $50 billion annually in medical costs to treat the cancers, lung disease, strokes and other ailments attributed to this addictive and deadly behavior. FDA has the support of the American people to regulate the use of cigarettes and smokeless tobacco. Tobacco is a major Presidential Initiative, and is receiving the support and cooperation of several federal and state agencies, including FDA. FDA has already issued regulations that prohibit retailers from selling tobacco to underage smokers, and require them to check photo ID's of all customers 27 years of age or younger. Resources have been proposed that will allow the Agency to initiate other aspects of this program.
FDA's Plan: The major components of the FDA strategy include: restricting access to tobacco; educating retailers about the new regulations; and beginning to implement processes for regulating tobacco. While the third strategic component is still pending, FDA is embarking on retailer compliance checks and retailer education. FDA's strategies are complementary to those of other federal agencies such as the CDC, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the National Cancer Institute (NCI). These partners are focusing research on the effects of smoking, long term education of the population, monitoring outcome data on smoking cessation, and on determining morbidity and mortality rates.
How Performance Will Be Measured: During FY 1999 and 2000, FDA's progress in the tobacco initiative will be measured by: 1) the degree of coverage achieved in conducting compliance checks among the estimated 500,000-1,000,000 tobacco retailers, and 2) the awareness levels of retailers concerning existing regulations. Outcomes such as smoking rates and mortality and morbidity figures will be monitored by FDA's sister agencies. The results of outcome monitoring will serve as input to adjusting any tobacco program strategies.
Coordination Across Organizations
Each of these strategic initiatives supports the FDA mission, as well as the objectives outlined in the strategic plan of the Department of Health and Human Services (DHHS), FDA's parent department (see Table A).
Table A
FDA Strategic Initiatives Relate to DHHS Strategic Objectives
| FDA Strategic Initiatives | |||||
| DHHS Objectives | Premarket Application Review | Product Safety Assurance | Food Safety Initiative | Injury Reporting | Tobacco |
| Reduce the major threats to the health and productivity of all Americans. |  |
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| Improve the economic and social well-being of individuals, families, and communities in the U.S. | |
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| Improve the quality of health care and human services. | |
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| Improve public health systems. | |
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| Strengthen the nation's health sciences research enterprise and enhance its productivity | |
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Table B illustrates how the responsibility for achieving the five major multi-year initiatives previously outlined is shared across FDA program areas.
Table B
FDA Strategic Initiatives Relate to Agency Programs
| FDA Strategic Initiatives | |||||
| FDA Programs | Premarket Application Review | Product Safety Assurance | Food Safety Initiative | Injury Reporting | Tobacco |
| Foods Program | |
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| Human Drugs Program | |
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| Biologics Program | |
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| Medical Devices and Radiological Health Program | |
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| Animal Drugs and Feeds Program | |
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| National Center for Toxicological Research | |
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| Tobacco Program | |
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FDA's Role as an NPR High Impact Agency
FDA is one of thirty-two federal agencies that have been designated "High Impact Agencies" by the National Partnership for Reinventing Government, primarily because they have the most interaction with the public and business. These agencies will work with NPR over the next three years to transform themselves into customer-oriented, results-driven organizations. The leaders of these agencies have each committed to a small number of significant, measurable goals that can be achieved over the next three years.
FDA's proposed reinvention goals are critical for the Agency's successful performance in the 21st century. Each of the goals requires new ideas, responsiveness to our "customers" (the American public) and close cooperation with key stakeholders. FDA will achieve the goals listed below provided that the current and projected funding levels for these initiatives are maintained.
More Efficient Drug Development: By the year 2000, reinvent the drug development and review process, thereby lowering the development costs, and, more importantly, reducing by an average of one year the time required to bring important new drugs to the American public. FDA will accomplish this through early and frequent consultation with product sponsors, implementation of an automated application filing process, and reauthorization of an enhanced user fee program.
Better Medical Product Information: In accordance with legislative mandate, 75 percent of all consumers receiving new drug prescriptions will be given more useful and readable information about their product by the year 2000. Usefulness is defined in terms of: scientific accuracy; unbiased content and tone; specificity and comprehensiveness; and timeliness. Based on national surveys conducted by FDA, the percentage of people who received useful information on new drug prescriptions was only 32 percent in 1992. To achieve the 75 percent goal, FDA will work closely with industry, health care providers and the consumer. Simultaneously, FDA will revise prescription drug and OTC labels to make them more readable. These information and labeling initiatives will improve the accurate use of medications and reduce risks associated with medication misadventures.
Stronger Food Quality Assurance: By the end of FY 2000, assure improved quality of the American food supply, through a collaborative system encompassing government and private sector stakeholders.* Eighty percent of the domestic seafood industry will be operating preventive controls as evidenced by functioning HACCP (Hazard Analysis Critical Control Point) quality control systems. HACCP is a newly instituted, industry-based monitoring system, and represents one element in the President's multi-strategy Food Safety Initiative. FDA will be working closely with USDA, EPA and the Centers for Disease Control and Prevention to implement this initiative.
* Assumes funding of the Food Safety Initiative through the year 2000.
Faster Access to Important New Medical Devices: By the year 2000, reduce the review time for important medical devices by 60 percent. (Important medical devices are products that present a major clinical benefit or those that may pose a significant risk to patients). This will be accomplished by reinventing the screening and review process for product applications. The impact of this goal is that millions of Americans will have faster access to safe and effective medical devices. FDA is reinventing the medical device review process and redefining the concepts of high risk and high impact products. The new definition will be applied to establish a baseline to measure review time for important medical devices.
The priorities represented by these four goal statements overlap with those described in FDA's Agency Performance Plan. Performance goals that support the accomplishment of these High Impact Agency goals are noted as such in Part Two of this plan.
Part Two: FDA's FY 2000 Performance Goals
As you read the performance goal section of the Performance Plan, you may wish to note these important points.
FDA's 2000 Plan:
Σbuilds on the 1999 Performance Plan. FDA's Year 2000 Performance Plan refers frequently to FY 1999 performance goals. While some goals have been changed or added, others may have been deleted in favor of goals that are more critical to current health concerns. A summary of the status of FDA's FY 1999 goals, with explanations of revisions to the goals, appears in Appendix 1. Appendix 2 provides a complete listing of FY 1999 and FY 2000 goal commitments.
Σresponds to guidance from Congress. The 1993 Government Performance and Results Act (GPRA), along with the Department (DHHS), place great value on achieving meaningful results through strategic planning. In the Year 2000 Performance Plan, FDA emphasizes the anticipated long-term results that can be achieved by reaching the performance goals set for the year 2000.
Σexplains the rationale for each strategic goal. Each of FDA's seven major program areas has included important information explaining why their major goals are important to protecting public health. By providing this context, readers should understand the rationale for each goal, as well as gain an appreciation for the investment needed.
Σtracks important data needed to measure progress. Whenever data are available, FDA includes that information to help track progress toward achieving each goal. In some cases, the data are already valid and reliable indicators of progress. In other cases, new ways of gathering meaningful data may be needed to monitor progress toward a goal. Data issues are addressed for each goal.
Σoutlines the resources needed to achieve results. The proposed investment in dollars and personnel is shown for each FDA program area.
Σhighlights our many partnerships. Because our mission is complex and affects so many products and all Americans, we work closely with scientists, health officials, policy makers, educators and the public. Some of our most important partnerships are highlighted in the plan.
Part Two describes the specific performance goals necessary to implement the strategic initiatives. The performance goals are organized by the Agency's program areas which also serve as the major categories in the Agency's budget. It is the responsibility of the managers within these programs to carry out the strategies necessary to achieve the performance goals.
The seven program areas within FDA's budget, and their functions, are:
Within each program area, there is a Verification and Validation section which addresses types of data sources used for measurement, reliance on current data sources and plans for enhancements, and limitations of the data.
Appendices
Appendix 1: Documents the current status of FDA's previously published FY 1999 performance goals.
Appendix 2: Provides a summary of FDA's FY 1999 and FY 2000 performance commitments.
Appendix 3: Focuses on FDA's import strategy. In this section, the Agency outlines its plan for ensuring the safety of all imports entering the United States. All of FDA's program areas contribute to the import initiative and the import effort is reflected in each of the program sections as well as in this appendix.
Appendix 4: A glossary of acronyms used in this document.
FY 2000 Program Resource Summary by Strategic Goal Area
| Program/Strategic Goal Area | Dollars ($000) |
FTEs | ||
| FOODS | 275,955 | 2,478 | ||
| Availability of Safe, Healthful Food Products | 31,294 | 244 | ||
| Foodborne Illness Prevention and Control | 223,835 | 2,047 | ||
| Intelligence on Food-related Injuries and Outbreaks | 11,026 | 90 | ||
| Nutrition Content, Cosmetics and Fraud | 9,800 | 97 | ||
| HUMAN DRUGS | 316,760 | 2,565 | ||
| Access to Safe, Effective Drugs | 198,780 | 1,855 | ||
| Injury From Adverse Reactions or Medication Errors | 46,592 | 126 | ||
| High-Quality Drugs | 71,388 | 584 | ||
| BIOLOGICS | 138,114 | 1,067 | ||
| Availability of Safe, Effective Drugs and Biologics | 30,685 | 187 | ||
| Safety of Blood and Blood Products | 72,286 | 542 | ||
| Compliance in Manufacture of Biologics | 35,143 | 338 | ||
| ANIMAL DRUGS AND FEEDS | 52,473 | 469 | ||
| Availability and Diversity of Safe Animal Products | 17,515 | 207 | ||
| Unsafe or Illegal Use of Products | 27,258 | 232 | ||
| Foodborne Illness | 7,700 | 30 | ||
| MEDICAL DEVICES AND RADIOLOGICAL HEALTH | 186,051 | 1,633 | ||
| Safe, Effective Devices Reviewed On Time | 70,325 | 639 | ||
| Safe, Effective Mammography Facilities | 21,317 | 147 | ||
| Detection and Prevention of Problems and Injuries | 19,199 | 151 | ||
| Domestic and Foreign Inspection Coverage | 49,862 | 448 | ||
| Science-Based Quality Assurance | 14,374 | 137 | ||
| Beneficial Use of Radiation at Minimal Risk | 10,974 | 111 | ||
| NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH | 33,679 | 227 | ||
| New Strategies For Prediction of Toxicity | 16,645 | 114 | ||
| Computer-based Predictive Systems | 4,714 | 32 | ||
| Method, Agent and Concept-Driven Research | 12,320 | 81 | ||
| TOBACCO | 68,000 | 40 | ||
| Reduce Access to and Appeal of Tobacco to Children | 42,000 | 29 | ||
| Enlist Retailers to Reduce Children's Use | 22,000 | 6 | ||
| Establish Regulatory Procedures for Tobacco Products | 4,000 | 5 | ||
Resource amounts are based on FY 2000 Request and include Budget Authority and User Fees.
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