FY 2007 HHS Annual Plan

Strategic Goal 2
Enhance the Ability of the Nation's Health Care System to Effectively Respond to Terrorism and Other Public Health Challenges

On this page:
Program 2a: Field Foods Program Food and Drug Administration (FDA)
Program 2b: Bioterrorism Hospital Preparedness Program Health Resources and Services Administration (HRSA)
Program 2c: Terrorism Preparedness and Emeergency Response Program Centers for Disease Control and Prevention (CDC)

Highlighted Programs:

• 2a. Field Foods Program (FDA)
• 2b. Bioterrorism Hospital Preparedness Program (HRSA)
• 2c. Terrorism Preparedness and Emergency Response Program (CDC)

HHS has a number of initiatives and programs directed at protecting Americans from bioterrorist attacks and other public health challenges. The events of September 11, 2001 and subsequent anthrax attacks have reinforced the HHS role in protecting Americans from attacks on our health and food supply by enhancing preparedness and response capabilities.

Approximately seven HHS programs in six OPDIVs contribute to achieving this strategic goal. Three programs are highlighted in this strategic goal including the Food and Drug Administration's (FDA) Field Food Program, Health Resources and Services Administration's (HRSA) Hospital Preparedness Program, and CDC's Terrorism Preparedness and Emergency Response Program.

In addition to responsive regulatory review of new biodefense medical countermeasures, FDA inspects high risk domestic food manufacturers and enhances food import inspections to protect our Nation's food supply and prevent food borne illness. HRSA assists hospitals and other medical facilities to prepare for health consequences of bioterrorism and other mass casualty events. CDC has an integral role in strengthening State and local public health infrastructure to effectively respond to emergencies.

The Office of Public Health Emergency Preparedness (OPHEP) was established to direct the Department's efforts in preparing for, protecting against, responding to, and recovering from all acts of bioterrorism and other public health emergencies that could affect the civilian population. OPHEP serves as the focal point within HHS for these activities, directing and coordinating the development and implementation of a comprehensive HHS strategy. The measures described in this section are representative of HHS progress towards building the necessary infrastructure to respond to bioterrorist and other public health challenges.

Program 2a: Field Foods Program
Food and Drug Administration (FDA)

Performance Measure: Perform prior notice import security reviews on food and animal feed line entries considered to be at risk for bioterrorism and/or to present the potential of a significant health risk.

The Field Foods Program promotes and protects the public's health by ensuring that the U.S. food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. As a result of the terrorist attacks of September 11, 2001, and the passage of the Bioterrorism Act of 2002, the FDA took on a food security/defense role to improve the protection of the nation's food supply, which is among the worlds safest.

The volume of all FDA-regulated imported shipments including food and animal feed has been rising steadily in recent years, and this trend is likely to continue. Between FY 2004 and FY 2005, FDA-regulated imports grew by 19 percent. In FY 2005 food and animal feed products comprised approximately 65 percent of the imported goods that FDA reviewed. To manage this ever-increasing volume, FDA uses risk management strategies to protect the public health.

Prior Notice Security Reviews are the most important counter-terrorism activity in the Field Foods Program. In FY 2007, FDA will continue to focus much of its resources on intensive prior notice import security reviews of products that pose the highest potential bioterrorism risks to the U.S. consumer and market. By FY 2007, FDA expects that the Prior Notice Center will have hired a permanent staff of Reviewers and Watch Commanders that will have achieved the training and gained the experience necessary to target additional threat parameters. The Prior Notice Center will receive feedback from import field exams and filer evaluations and begin targeting those individuals that continuously violate the law and commodities based on immediate and potential threats to the integrity and security of the intact food supply chain. In addition, broader surveillance of products imported from countries considered to be at a higher risk for terrorist activities can be incorporated into targeting goals. Strategies used to ensure effective targeting will include:

• Intelligence regarding countries at risk for terrorism;
• Intelligence regarding commodities susceptible to or exploited by terrorism;
• Intelligence specific to shipment or shipping entities;
• Information gleaned from Foreign and Domestic Establishment Inspection Reports that identify security breaches;
• Sample collection and analysis for counterterrorism;
• Prior Notice discrepancies reported during import field exams; and
• Filer evaluation field audits.

FDA anticipates that the measures that it uses to assess its success in monitoring the safety and security of imported products will continuously evolve as trade practices and information about risks change.

The prior notice requirement of the Bioterrorism Act became effective in December of 2003. In 2007, FDA expects to perform 60,000 prior notice reviews. In FY 2005, FDA achieved its goal by collaborating with the Department of Homeland Security's Customs and Border Protection to direct field personnel to conduct 86,187 intensive security reviews of prior notice submissions in order to intercept contaminated products before they entered the food supply. This exceeded the FY 2005 target by 48,187. In FY 2004, FDA collaborated with Customs and Border Protection to direct field personnel to hold and examine 20 suspect shipments of imported food; responded to 20,430 inquiries; and conducted 33,111 intensive reviews of prior notice submissions out of 6,294,821 in order to intercept contaminated products before they entered the food supply.

As FDA continues to develop its relationship with the Department of Homeland Security's Customs and Border Protection organization, practices, procedures and regulations may change that will result in changes in Prior Notice Security Review activities.

The import security reviews that are performed by the Prior Notice Center are performed on those prior notice submissions that are selected after intelligence, known risk factors and information available about the manufacturer, shipper, and consignee are applied to the prior notice submission data. The selection of candidates for security review is not related to the volume of submissions; they are selected on the basis of risk factors. If threats are reduced, then it is possible for the number of security reviews to decline. One possible circumstance might be the suspension of imports from a country or countries whose potential imports trigger many security reviews. Another possibility could be dramatically increased numbers of reviews because of newly identified risk factors. The estimate of the number of security reviews to be performed is simply an estimate based on the recent past. In today's risky environment, it may be well over or under, the number that will be performed. It is the quality of the targeting information and the quality of the review itself that provides the security, not the proportion of potential items selected for security review.

Program 2b: Bioterrorism Hospital Preparedness Program
Health Resources and Services Administration (HRSA)

Performance Measure: Percent of awardees that have developed plans to address surge capacity.

A terrorist attack or other large-scale emergency could result in a demand for health care that could rapidly overwhelm the resources in a specific region. The National Hospital Preparedness program works to maximize surge capacity in the event of such an emergency. Surge capacity is the ability to evaluate and care for a markedly increased volume of patients. The requirement to develop plans to address surge capacity is based on the concept that improved outcomes can be achieved when critical components of preparedness are organized into a system of care.

Plans for surge capacity must address the following issues: (1) hospital bed capacity for adults and children; (2) the capability for isolation and decontamination; (3) appropriate staffing; (4) appropriate medical prophylaxis and treatment for hospital staff and their family members; (5) personal protective equipment; (6) capacity for trauma and burn care; (7) capacity for mental health care; (8) communications and information technology; and (9) hospital laboratory connectivity and capacity.

The FY 2007 target measure is for 100 percent of grant recipients to have developed plans to address surge capacity.In FY 2005, 100 percent of Hospital Preparedness program awardees had developed surge capacity plans, meeting the target. This represented an increase from 89 percent in FY 2004. In the future, the program will track various aspects of the implementation of these plans.

A PART review of the Bioterrorism Hospital Preparedness Program was conducted for the FY 2005 budget; the program received a rating of Results Not Demonstrated. The assessment found that the purpose and importance of this effort are clear and that the effort is well coordinated with other Federal preparedness efforts. The review also noted that the program has not yet demonstrated results due its relative newness and the inherent difficulty of measuring preparedness against an event that does not regularly occur. The program notes, in this context, the added challenge of measuring the relatively new and evolving concept of preparedness.

The assessment recommended that the program work with State and local representatives to ensure that performance information will be available. This work is underway. The additional annual performance measures developed during the PART review very early in the life of the program are no longer applicable as they are inconsistent with the evolution of the program and the elements identified in the National Preparedness Goal and its companion documents. They also fail to reflect the direction and focus of the current preparedness efforts. Given this, the Hospital Preparedness Program has reexamined the specific elements of these measures and will propose modifications, in consultation with DHHS and the Administration, to improve the program's ability to monitor performance in the future.

As the Nation, and more specifically the NBHPP, moves to support the National Preparedness Goal, which includes medical surge as one of the four specified capability priorities for the country, certain levels of responsibility will be assigned to local, state, and regional governments to develop and maintain. In FY 2007 the program will continue to focus heavily on the following areas of capability required to perform assigned missions and tasks: personnel, planning, organizational leadership, equipment and systems, training and exercises, evaluations, and corrective actions. Further, promotion of interstate regional planning will be emphasized with more focus on exercises, drills and after action reports (to confirm the competence of healthcare providers).

Strategic Goal 2c: Terrorism Preparedness and Emergency Response Program
Centers for Disease Control and Prevention (CDC)

Performance Measures:

• 100 percent of State public health agencies are prepared to use material contained in the SNS as demonstrated by evaluation of standard functions as determined by CDC.
• 100 percent of State public health agencies improve their capacity to respond to exposure to chemicals or category A agents by annually exercising scalable plans and implementing corrective action plans to minimize any gaps identified.

Following are the CDC preparedness goals:

1. Prevent: Increase the use and development of interventions known to prevent human illness from chemical, biological, radiological agents and naturally occurring health threats.
2. Detect / Report: Decrease time needed to classify health events as terrorism or naturally occurring in partnership with other agencies.
3. Detect / Report: Decrease time needed to detect and report chemical, biological, and radiological agents in tissue, food, or environmental samples that cause threats to the public's health.
4. Detect / Report: Improve the timeliness and accuracy of communications regarding threats to the public's health.
5. Investigate: Decrease time to identify causes, risk factors, and appropriate interventions for those affected by threats to the public's health.
6. Control: Decrease time needed to provide countermeasures and health guidance. Activities include distribution of materials from the Strategic National Stockpile (SNS).
7. Recover: Decrease time needed to restore health services and environmental safety to pre-event levels.
8. Recover: Improve long-term follow-up provided to those affected by threats.
9. Improve: Decrease time needed to implement recommendations from after-action reports. Activities include State and Local Readiness cooperative agreement and program services.

Strategic National Stockpile (SNS)

CDC, in A Guidance for Preparedness, V 10.00, describes 12 functions of SNS Preparedness required for the effective management and use of deployed SNS materiel. Based on these functions, State and local public health grantees are required to develop SNS Preparedness Plans detailing the performance of these functions during an emergency. In an effort to enhance grantee planning efforts, the SNS program maintains a staff of Program Services Consultants who provide ongoing technical advice and training assistance to grantees. The consultants also evaluate the grantee's level of preparedness to receive, distribute and dispense SNS assets. As of December 2005, 76 percent (41/54) of the states and directly-funded cities have met the minimum standards for demonstrating preparedness to use SNS assets. The FY 2007 target is to achieve a level of 90 percent of grantees meeting the minimum standards.

State and Local Preparedness and Planning

In order for state and local public health agencies to test their capabilities for responding to bioterrorism, chemical exposures, and other public health emergencies, CDC recommends that response plans be tested regularly by staff participation in exercises and simulation drills. Lessons learned from both responses to real events and annual exercises can help identify gaps in preparedness planning and should result in improved public health responses.

The FY 2005 target that 25 percent (at least 15) of states/territories/grantees conduct an exercise to evaluate their plans and response systems was exceeded with 94 percent (47/50) of State public health agencies exercising the plan for at least one of these priority agents. In future years, grantees will need to implement corrective actions within 90 days of identifying a deficiency through a drill, exercise, or real event. The FY 2007 target expects that 100 percent of grantees will meet requirements in these areas.

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