This document has been superseded by the FDA FY 2000 Performance Plan. Final FY 1999 performance commitments are found in Appendix 2 of the FY 2000 plan.

DEPARTMENT
of HEALTH
and HUMAN
SERVICES

Fiscal Year
1999

Food and Drug Administration

Performance Plan

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

TABLE OF CONTENTS

Part I: Overview
   
 
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.)

Introduction to the Food and Drug Administration's
FY 1999 Performance Plan

This document is a management window into the FDA, an agency that affects every American every day. In this performance plan, FDA proposes very specific goals to carry out its mission in Fiscal Year (FY) 1999. These goals commit FDA to:

The uses of the FY 1999 Performance Plan are many. For example:

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Layout of the Plan

Part I: Overview

  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.

Part II: Budget and Program Summaries

  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:


 
  • FY 1999 Resources: Anticipated costs and for programs and personnel

  • Strategic Future: Facts and insights into emerging issues

  • Clusters: The most closely related performance goals

  • Performance Goals: Specific accomplishments the agency plans for the year

  • Performance Measurement: Guidelines for determining when results are achieved

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.

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FDA Mission

In 1997, for the first time in history, Congress codified FDA's mission statement into law (Public Law 105-115). This new mission not only addresses the specific public health responsibilities such as those relating to food and drug safety, but it also emphasizes the manner in which those responsibilities will be carried out, such as through collaboration with consumers, manufacturers, importers and retailers of regulated products.

Mission of the
Food and Drug Administration

  1. To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;

  2. With respect to such products, protect the public health by ensuring that:
    • foods are safe, wholesome, sanitary, and properly labeled;
    • human and veterinary drugs are safe and effective;
    • there is reasonable assurance of the safety and effectiveness of devices intended for human use;
    • cosmetics are safe and properly labeled, and;
    • public health and safety are protected from electronic product radiation.

  3. Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and

  4. As determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of regulated products.

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Linkage to Department of Health and Human Services
Mission and Strategic Plan

FDA's FY 1999 Performance Plan carries out the mission of its parent agency, the Department of Health and Human Services (DHHS). The DHHS mission is:
"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:

  1. Assure food and drug safety by increasing the effectiveness of science-based regulation.

  2. Accelerate private-sector development of new drugs, biologics, therapies, and medical technology.

  3. Reduce tobacco use, especially among youth.

  4. Improve the diet and level of physical activity of Americans.

  5. Promote the appropriate use of effective health services.

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FDA's Key Performance Commitments

The next section highlights FDA's most important performance commitments relating to its mission: food safety, premarket review, tobacco, and partnerships. These four commitments, coupled with the Agency's performance goals, budget priorities, and program areas outlined later in this plan, support the new mission. And even though the ultimate outcomes may not be achieved until after 1999, they represent the Agency's highest priorities during FY 1999.

Key Performance Commitment #1

Food Safety Initiatives

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.

Key FY 1999
Performance
Goals:
  • Develop improved baseline surveillance data of foodborne illness.
  • Reduce the prevalence of reported risky food consumption behaviors.
  • Reduce the prevalence of reported risky food preparation practices.
  • Assure that 50 percent of the seafood industry is operating under appropriate hazard assessment and control systems (Hazard Analysis and Critical Control Point - HACCP).
  • Begin implementing HACCP systems in the juice industry.
  • Achieve adoption of the Food Code by 25 percent of states.
  • Assure that 40 percent of domestic produce is grown and processed using good agricultural and manufacturing practice guidance for minimizing microbial contamination.
  • Develop scientific methods for minimizing microbial contamination on fresh produce.
  • Study factors that cause foodborne pathogens to develop multiple antibiotic resistance and resistance to traditional food preservation techniques.

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Key Performance Commitment #2

Premarket Review

Outcomes:
  1. Reduce the time required to bring important new drugs to the public; and,
  2. Improve public access to important new medical devices, vaccines, and food additives.
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:
  • Act on 90 percent of priority new drug applications within 6 months of submission.
  • Act on 90 percent of priority biological (e.g. blood, vaccines, therapeutics) applications within 6 months of submission.
  • Act on 60 percent of original generic drug applications within 6 months of submission.
  • Act on 50 percent of important new medical device applications within 6 months of submission.
  • Act on 30 percent of direct food additive petitions within 12 months.
  • Continue to move toward paperless, electronic submission of drug applications.

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Key Performance Commitment #3

Tobacco

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.
Key FY 1999
Performance
Goals:
  • Conduct an average of 42,000 unannounced compliance checks each month of retail establishments that sell tobacco products.
  • Educate retailers and other stakeholders about the FDA tobacco rules through a multimedia campaign including point-of-purchase, radio, outdoor advertising, and newspapers.
  • Design and implement a regulatory program for cigarettes and smokeless tobacco products.

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Key Performance Commitment #4

Partnerships for Health Protection

Outcome: Launch a more effective national response to public health risks through partnerships and shared responsibilities.
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.
Key FY 1999
Performance
Goals: 		With consumers' help, increase public understanding of food and drug labeling.
  • 85 percent of adults will use food labels to make nutritious food selections.
  • Continue to improve the legibility and clarity of over-the-counter drug labels.

With state partners, improve compliance with quality health regulatory standards.
  • Ensure that at least 97 percent of mammography centers meet key inspection standards.
  • Expand State Partnership Agreements to at least one per state to improve Federal- state coordination on health issues.
  • Ensure compliance with good manufacturing practices including the new BSE (Mad CowDisease) regulation through education and inspections.

With national and global partners, reduce the health risks of imported products.
  • Directly examine 3 percent of potentially high-risk imports.
  • Increase percentage of imports screened within 15 minutes to 55 percent.

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FDA Programs

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.

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Strategic Framework

The "strategic framework" (shown below) reflects FDA senior managers' most significant performance directions for the Agency. This framework represents key strategic directions into the 21st Century. The framework emphasizes essential elements in the FDA and DHHS missions and includes critical practices outlined in the Government Performance and Results Act (GPRA). By using this framework across the Agency, FDA has challenged itself to emphasize results instead of process goals.

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
PREMARKET
REVIEW
POSTMARKET
ASSURANCE
INTERNAL
CAPACITY
EXTERNAL
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

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Measuring, Monitoring and Reporting on Results

FDA's approach to performance-based management consists of the following stages:

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.

Performance improvement process chart

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
  • CDC's Office of Smoking and Health national survey database and the National Institute on Drug Abuse's (NIDA) Monitoring the Future Project national survey are cooperative systems that FDA will use to measure goals relating to young people's initial use of tobacco.

   
Premarket
  • The Center-wide Oracle Management Information System (COMIS) helps ensure new drug applications are reviewed and processed within time frames established in the FY 1999 Performance Plan.

  • The Compliance Status Information System (COMSTAT) is a data system for sharing FDA inspection information with foreign regulatory authorities, enabling drug manufacturers and foreign governments to expedite the marketing of new, safe and effective drugs (an important FDA goal).

   
Partnerships
  • Operational and Administrative System for Import Support (OASIS) is an automated tracking system that helps speed safe imported products to the American people, and restrict distribution of unsafe products. This system has been designed and implemented in collaboration with the U.S. Customs Service.

   
Food Safety
  • FDA is working with CDC and USDA to build FoodNet, a national foodborne illness active surveillance system. As part of the interagency Food Safety Initiative, this system will enable us to establish the occurrence and magnitude of foodborne illness outbreaks and allow for tracing back to the source of each outbreak.

  • The National Seafood HACCP Compliance Database will be used to determine how well the seafood industry is meeting the seafood safety standards and to help FDA focus training and technical assistance where needed.

  • FDA's Field Data System is another database for determining how well the milk, shellfish, and retail food establishments are meeting the safety/sanitation standards and provides the information that helps the industry in evaluating the effectiveness of these standards.

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.

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Introduction to Budget and Program Summaries

Part II of the plan shows the "Budget and Program Summaries" for FY 1999 that begins October 1, 1998. The resource levels requested in FDA's FY 1999 Congressional Budget will support the proposed goals described in this Performance Plan. The following section is organized in the same way as the Agency's FY 1999 Congressional Budget to allow for easy cross-referencing between the two documents. FDA provides the following information about each program's proposed goals for FY 1999, arranged in order by program areas.

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.

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FY 1999 PROGRAM RESOURCE SUMMARY
(BY CLUSTER)

Program/Cluster $000 FTEs
FOODS
  Food and Color Additive Review 18,380 200
  Food Safety Assurance 166,078 1,623
  Internal Capacity Building 37,420 342
  Coordination 26,839 278
  Program Total 248,717 2,443

HUMAN DRUGS

  Premarket Review 197,984 1,533
  Postmarket Assurance 12,145 547
  Internal Capacity 66,646 404
  External Leverage 13,088 171
  Program Total 289,863 2,655

BIOLOGICS

  Prescription Drug User Fee Act 64,608 493
  Blood and Blood Components 35,587 424
  Biologics Compliance 24,233 159
  Program Total 124,428 1,076

ANIMAL DRUGS AND FEEDS

  New Animal Drug Review 18,906 186
  Postmarket Assurance 26,068 257
  Program Total 44,974 443

MEDICAL DEVICES AND RADIOLOGICAL HEALTH

  Premarket Review 55,035 620
  Science, Technology and Standards 10,890 121
  Postmarket Assurance 14,590 163
  Compliance 38,152 416
  Mammography Quality Standards Act 24,580 111
  Radiation Control for Health and Safety Act 12,707 139
  Program Total 155,955 1,569

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

  Build Knowledge Bases 4,593 15
  Develop New Stratgies for the Prediction of Toxicities 10,222 82
  Methods-, Agent-, Concept-Driven Research 16,764 128
  Program Total 31,579 225

TOBACCO

  Tobacco 134,000 50
  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).

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