U.S. Food and Drug Administration
Performance Plan
2002

Part Three: FDA Strategic Goals, FY 2002 and 2003 Performance Goals, and FY 2001 Performance Accomplishments

In Part Two of FDA's Performance Plan, each of the Agency's four strategic goals will be explained in greater depth. This Part is organized into four sections--one corresponding to each strategic goal. In each section, the following topics will be covered:

Desired Outcome--What impact does FDA hope to achieve?

Why FDA's Contribution is Important--What role does the Agency play in achieving the end result?

Key Strategies--What are the major elements of FDA's approach to achieve the strategic goal?

Current Status and Barriers to Future Progress--What is FDA's current performance in this area, what is the gap between actual and ideal performance, and what is preventing us from narrowing the gap?

Summary of Performance Goals and Accomplishments--This table will report on the status of FY 2001 performance goals; identify final FY 2002 performance goals based on Congressional appropriations; and indicate FY 2003 performance goals that are achievable with the President's budget proposal.

Strategic Goals

Counter the Terrorist Threat

Maintain a Strong and Effective FDA

Assure Medical Product Safety

Bring New Technologies to a World Wide Market

Countering the Terrorist Threat

Desired Outcome

Ensure that U.S. citizens are protected from public health threats posed by unexpected and potentially widespread terrorist attacks.

Why FDA's Contribution Is Important

The terrorist attacks of September 11 have required FDA to play a critical role in the national effort to combat future threats.

There is little experience in this country with deliberate terrorist incidents aimed at the civilian population. FDA must be vigilant in assessing and then quickly and effectively reducing risk associated with unexpected and potentially widespread health and safety threats to the U.S. public. Preparedness and response to potential terrorism acts are complicated by the unpredictable and multi-faceted nature of these hazards.

A combination of public health and law enforcement responsibilities requires FDA's involvement in a number of aspects of the preparedness for and response to terrorist activities. FDA's responsibilities encompass both the civilian and military sectors of the population, broadening the scope of the Agency's counter terrorism activities.

Key Strategies

FDA has developed an integrated strategic approach to address the threat of terrorism in the U.S. These strategies have the following characteristics:

• They build upon existing Agency capacities to manage health and safety risks;
• They leverage the strengths of health, scientific and law enforcement agencies to create a potent counter attack against terrorism; and,
• They create intelligence synergies by bringing the right combination of information to crucial decision points.

The total effect is creation of a safety net that significantly reduces the probability that terrorists will ever achieve their aims; and minimizes the impact of these threats if they do occur.

This safety net consists of four strategies:

• Protect regulated products: Deter, detect, investigate and interdict terrorist threats before they become a reality;
• Develop medical counter measures to minimize the impact of attacks on the population;
• 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; and,
• Ensure that radiation devices used to diagnose or treat terrorist-related incidents are safe and effective.

Each of these strategies is described in detail below.

Protect Regulated Products: Deterrence, Detection, Investigation, and Interdiction--This strategy focuses on decreasing the threat of contamination of the food supply, drug tampering or counterfeiting, sabotage of critical medical products, and contamination of animal feed. To be successful, FDA must monitor products from their source of production through the entire distribution system to the point of consumption. Three primary objectives are to:

1. Ensure Import Security--minimizing the threat at the country of origin before products are exported to the U.S.; and at the border so that hazardous products never enter the country. The latter will require greatly enhanced manpower and analytical capability at ports of entry;
2. Ensure Domestic Product Security--strengthening inspection coverage of domestic plants, augmenting product and pathogen testing, and closely monitoring product consumption to detect any pattern of adverse events that may stem from terrorist-related incidents; and,
3. Integrate Information to support risk management decisions--gathering, synthesizing and performing critical analysis of intelligence information and providing that information to those responsible for minimizing threats to the U.S. public health.

Medical Countermeasures--The purpose of this strategy is to assure drugs, vaccines, blood, medical devices and other medical products are available to prevent, diagnose or treat illnesses or injuries resulting from terrorist attack or battlefield injury. Key objectives are to:

1. Facilitate medical product development--stewarding the development of safe and effective drugs, vaccines and medical devices that can be promptly available to protect the public health and safety in the event of a attack;
2. Ensure availability of medical products-- working with federal health and defense agencies to maintain and manage the stockpile of medical products so that they are available in sufficient quantities to address public health emergencies; and,
3. Maintain the balance of public health needs and legal mandates to ensure safety--both interests must be satisfied in monitoring and controlling medical product use at the various stages of the medical product life cycle.

Emergency Preparedness and Response--Pivotal among FDA's strategies is to adequately prepare for, and promptly and effectively respond to terrorist attacks. Key objectives are to:

1. Enhance the Agency's emergency preparedness plan to establish protocols for responding to terrorist attacks;
2. Develop and implement, as needed, emergency contingency plans for specific terrorist incidents;
3. Establish a plan for continuity of FDA operations in an emergency; and,
4. Ensure the safety and security of FDA's most important assets--FDA personnel, physical assets, and information.

Radiation Safety--This country has long overlooked the criticality of radiation safety in day to day operations. FDA's fourth strategy focuses on radiation-emitting devices that are used to: detect potential security threats--e.g. in airports; destroy pathogens that may be released in a terrorist incident; and treat victims of terrorist-generated radiation incidents. This strategy also addresses the efficacy of devices that are used to detect the presence of radiation associated with terrorist events. Within this strategy key objectives are to:

1. Ensure that radiation-emitting products used for security screening or irradiation are safe both for human operators and human subjects;
2. Facilitate development and efficient distribution of medical counter measures to address radiation incidents; and,
3. Develop a radiological health emergency preparedness program.

Current Status and Barriers to Future Progress

The President's proposed budget for counter terrorism significantly strengthens FDA's ability to counter the terrorist threat. The proposal narrows the gap between the ideal and the actual state of affairs in three areas in particular:

1. Food Safety;
2. Medical Product Availability and Safety;
   and,
3. Internal Security.

In the area of Food Safety, the President's Budget annualized the FY 2002 Budget Supplemental for Counter Terrorism; and this will enable FDA to enhance inspection and analytical coverage of imported products. This will have the effect of more than doubling the Field import staff and substantially increasing the number of physical exams and laboratory analyses conducted at the border.

The Operational and Administrative System for Import Support (OASIS) will be enhanced to provide improved targeting of intelligence about suspected terrorism activities that might affect imports.

In addition, the Agency will be developing a Continuity of Operations Plan (COOP) which will allow the Agency to keep its major programs functioning in the event of a disabling attack.

High Performance Liquid Chromatography (HPLC) equipment will be purchased for rapid analysis of suspect foods for Select Agents toxins and other agents that could be used in a terrorist event.

On the domestic front, the Electronic Laboratory Exchange Network (eLEXNET) will be expanded to include more state health laboratories. The Network will also expand its capability to exchange data on select biological agents (possibly including anthrax, botulinum toxin, brucellosis and other potential infectious diseases.

This system is the first Internet-based food safety system that consolidates and shares pathogenic findings among Federal, State, and local government labs;

Additional increases are proposed to enhance medical product availability. Increased funds will be used to develop drugs, vaccines and medical devices that will counteract the intentional use of biological, chemical, or nuclear agents.

Internal security of FDA's facilities will be enhanced by proposed funding to:

• Increase physical security and provide for increased guard services, improved security systems, and physical barriers at the entrances to the Agency's buildings and parking lots;
• Secure storage for select agents, including lockable storage cabinets, refrigerators and freezers to prevent unauthorized use or theft;
• Develop and Validate rapid test methods for the detection of agents that could be deliberately introduced into the food supply; and,
• Upgrade designated laboratory facilities at NCTR (located in the Jefferson Laboratories of the FDA in Jefferson Arkansas) to a BioSafety Level 3 (BSL-3) to support BSE/TSE and microbial counter terrorism research.

FDA has developed a FDA five-year strategic plan to counter terrorism. This Plan proposes a staged solution that will ultimately bring the Agency to an ideal state of readiness in addressing the terrorist threat to this Nation. Strategies outlined for FY 2002 and FY 2003 are first steps toward the long-term solution.

Specific performance commitments for FY 2002 and FY 2003 and actual performance from FY 2001 are outlined in the table that follows.

Performance Goals Summary

 

FY 2001 Performance Report			FY 2002 - 2003 Performance Goals
Program	FY 2001 Goal	FY 2001 Status	FY 2002 Goal	FY 2003 Goal
Deterrence, Detection, Investigation and Interdiction -- Focus on Food Safety
Foods Goal 1	Complete the safety evaluation of 55 percent of the number of food and color additive petitions that were under review for more than 360 days at the beginning of the Fiscal Year.	FY 2001: 10/02	For the petition receipt cohort of FY 2001, complete within 360 days of filing, the safety evaluation of 60 percent of food and color additive petitions that do not qualify for expedited review.	For the petition receipt cohort of FY 2002, complete within 360 days of filing, the safety evaluation of 65 percent of food and color additive petitions that do not qualify for expedited review.
Foods Goal 2	Respond to 90 percent of notifications for dietary supplements containing "new dietary ingredients" within 75 days.	FY 2001: 100 percent	Respond to 95 percent of notifications for dietary supplements containing "new dietary ingredients" within 75 days.	Respond to 95 percent of notifications for dietary supplements containing "new dietary ingredients" within 75 days.
Foods Goal 4	NA	NA	Review 95 percent of premarket notifications for food contact substances in the receipt cohort of FY 2002 within the statutory time limit (120 days).	Review 95 percent of premarket notifications for food contact substances in the receipt cohort of FY 2002 within the statutory time limit (120 days).
Foods Goal 5	NA	NA	NA	Publish a final rule to require premarket notification for bioengineered foods.
Foods Goal 6	Achieve adoption of the Food Code by at least one state agency in 25 states in the USA.	FY 2001: 28	Achieve adoption of the Food Code by at least one state agency in 28 states in the USA.	Achieve adoption of the Food Code by at least one state agency in 33 states in the USA.
Foods Goal 7	Inspect 95 percent of high-risk domestic food establishments once every year.	FY 2001: 74 percent	Inspect 95 percent of high-risk domestic food establishments once every year.	Inspect 95 percent of high-risk domestic food establishments once every year.
Foods Goal 11	NA	12,169 physical exams conducted on food imports	Increase food import surveillance by hiring 300 new investigators and analysts who will increase the number of physical exams by 97 percent to 24,000 and conduct sample analyses on products with suspect histories.	Increase the number of physical exams by 100% (48,000 exams) and conduct sample analyses on products with suspect histories.
Foods Goal 12	NA	NA	Extend import coverage to an additional 45 ports that handle significant quantities of FDA-regulated products.	Enhance productivity at the additional ports through focused training
Foods Goal 13	Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 samples.	FY 2001: 10/02	Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 samples.	Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 samples.
NCTR Goal 6	NA	NA	Acquire high-resolution mass spectrometer for use with protein from bacteria, food toxins and genomics studies.	NA
NCTR Goal 6	NA	NA	Upgrade existing laboratory facilities to BSL-3 to support BSE/TSE and microbial bioterrorism work.	Outfit upgraded laboratory, provide for supplies (agents, chemicals/pathogens) and construct library databases of proteins and test to find toxin related markers.
NCTR Goal 6	NA	NA	Recruit additional expertise in Computational Science, Chemistry and Microbiology.	Recruit additional expertise in Computational Science, Chemistry and Microbiology.
Medical Product Availability and Safety
Human Drugs Goal 5	NA	NA	Publish a Guidance for Industry on developing antimicrobial drugs for inhalational anthrax (post-exposure).	NA
Human Drugs Goal 6	NA	NA	Facilitate the initiation of research in a non-human primate model of pneumonic plague	NA
Human Drugs Goal 7	NA	NA	Expedite the review of protocols for investigational new drugs (INDs) to treat organophosphorous nerve agents in the event of a chemical attack. Encourage sponsors of these new drug applications (NDAs) to update current labeling for Antidote Treatment - Nerve Agent, Autoinjectors (ATNAA).	NA
Human Drugs Goal 8	NA	NA	NA	Identify and begin to address labeling gaps in the therapeutic armamentarium for the prevention, mitigation, and treatment of illnesses cases by chemical and biological attacks, including the needs for special populations, such as pregnant women, pediatric, and geriatric populations.
Human Drugs Goal 9	NA	NA	NA	Develop a Guidance for Industry on developing antiviral drugs for the mitigation of complications associated with vaccinia immunization.
Human Drugs Goal 10	NA	NA	NA	Facilitate human clinical trials in pneumonic plague for antimicrobial drugs that are not yet labeled for this treatment indication.
Human Drugs Goal 11	NA	NA	NA	Develop a Guidance for Industry on developing antiviral drugs for the treatment of smallpox.
Human Drugs Goal 12	NA	NA	Publish a final rule that allows the Agency to approve new drug and biological products for the treatment of chemical, biological, radiological, or nuclear substances based on animal efficacy studies when adequate and well-controlled studies in humans cannot be ethically conducted and field studies are not feasible.	NA
Human Drugs Goal 19	NA	NA	Publish a Notice of Proposed-Rulemaking to establish a web-based electronic animal and human drug and biologics registration and listing database to allow for complete and up-to-date data on all regulated drug products.	Finalize rulemaking to establish a web-based electronic drug registration and listing database to allow for complete and up-to-date data on all regulated drug products, and follow this finalization with launch of the electronic database.
Human Drugs Goal 20	NA	NA	Publish a Notice in the Federal Register on doxycycline and penicillin G procaine dosing recommendations for inhalational anthrax.	NA
Biologics Goal 6	NA	NA	NA	Expedite review of product specific lot release and extension of dating submissions for the Anthrax Vaccine Absorbed (AVA).
Biologics Goal 7	NA	NA	NA	Provided guidance to the CDC, DOD and the Anthrax Vaccine Absorbed manufacturer regarding clinical studies to support proposed changes in the immunization schedule and routes of administration.
Biologics Goal 8	NA	NA	NA	Facilitate expedited development and review of new vaccines for protection and/or treatment against bioterrorism related threat diseases (e.g., smallpox and anthrax vaccines).
Biologics Goal 9	NA	NA	NA	Facilitate expedited development and review of new gamma globulins for protection and/or treatment against bioterrorism related threat diseases.
Biologics Goal 10	NA	NA	NA	Evaluate the need for guidance documents to assist in the development of products such as immunoglobulins and select vaccines.
Emergency Preparedness and Response-- Focus on Internal Security
Administrative Management Goal 7	NA	NA	Develop a continuity of operations plan (COOP) for FDA, and participate with PSC in development of a Parklawn COOP	Finalize and implement the Plan.
Administrative Management Goal 8	NA	NA	Enhance the Agency Emergency Preparedness plan to establish protocols for responding to terrorist attacks	NA
Radiation Safety
Human Drugs Goal 13	NA	NA	NA	Expedite the review of protocols for investigational new radioprotectant drugs (including heavy metal chelators) for use in the event of a radiation emergency.
Human Drugs Goal 21	NA	NA	Issue guidance on the use of potassium iodide (KI) as a thyroid blocking agent in radiation emergencies.	NA
Medical Devices Goal 4	NA	NA	NA	Expedite review for 100 percent of Bio-terrorism Diagnostic medical device applications.
Medical Devices Goal 14	NA	NA	Develop Emergency Counter Terrorism Preparedness and Response Plan for radiation.	Implement Emergency Counter Terrorism Preparedness and Response Plan for radiation.
Medical Devices Goal 15	NA	NA	NA	Begin to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places.

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