Contents:
July 2007
This document consists of a compendium of actions due to be completed within 12 months of the release of the National Strategy for Pandemic Influenza Implementation Plan (Implementation Plan), along with responses from departments and agencies.
The actions below are reproduced from the Implementation Plan. Each action is followed by a summary of progress, in italics, prepared by relevant departments and agencies for this report. The assessment is indicated directly after the action number. A determination of “complete” indicates that the measure of performance has been met but does not necessarily mean that work has ended; in many cases work is ongoing. A determination of “in progress” indicates that the measure of performance has not yet been met and additional work is being done to meet the appropriate standard.
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[Note: Chapters 1 - 3 of the Implementation Plan do not contain action items. This assessment of action item progress commences with Chapter 4.]
4.1.1.1. Complete
DOS, in coordination with HHS, USAID, DOD, and DOT, shall work with the Partnership, the Senior UN System Coordinator for Avian and Human Influenza, other international organizations (e.g., WHO, World Bank, OIE, FAO) and through bilateral and multilateral initiatives to encourage countries, particularly those at highest risk, to develop and exercise national and regional avian and pandemic response plans within 12 months. Measure of performance: 90 percent of high-risk countries have response plans and plans to test them.
We have emphasized preparedness as an important aspect in addressing the international threat of pandemic influenza – especially the preparation of response plans. The United States chaired a session at the June 2006 meeting of the International Partnership on Avian and Pandemic Influenza in Vienna and in August 2006 led the APEC Health Task Force Seminar on Assessing Pandemic Preparedness. To date, 90 percent of countries considered to be at high risk for an avian or pandemic influenza outbreak have developed response plans and many of them have been tested through exercises or real-world responses. WHO reports that 178 countries have national pandemic preparedness plans. We will continue to encourage countries to test, evaluate, and improve their response plans.
4.1.1.2. Complete
USDA, USAID, and HHS shall use epidemiological data to expand support for animal disease and pandemic prevention and preparedness efforts, including provision of technical assistance to veterinarians and other agricultural scientists and policymakers, in high-risk countries within 12 months. Measure of performance: all high-risk and affected countries have in place (1) national task forces meeting regularly with representation from both human and animal health sectors, government ministries, businesses, and NGOs; (2) national plans, based on scientifically valid information, developed, tested, and implemented for containing influenza in animals with human pandemic potential and for responding to a human pandemic.
More than 80 percent of all high-risk countries have national task forces in place and have either developed or are working to develop national plans for responding to the threat of avian and pandemic influenza. To further strengthen global preparedness and planning, we are providing technical assistance and direct support for planning efforts to government ministries, international organizations, and private sector partners, so that they can put into operation national avian and pandemic plans in 57 countries. We are also assisting efforts to increase surveillance, prevention, and containment capacity at both the national and local levels. Since 2005, we have supported training for more than 129,000 animal health workers and 17,000 human health workers.
4.1.2.1. Complete
DOS shall ensure strong USG engagement in and follow-up on bilateral and multilateral initiatives to build cooperation and capacity to fight pandemic influenza internationally, including the Asia-Pacific Economic Cooperation (APEC) initiatives (inventory of resources and regional expertise to fight pandemic influenza, a region-wide tabletop exercise, a Symposium on Emerging Infectious Diseases to be held in Beijing in April 2006 and the Regional Emerging Disease Intervention (REDI) Center in Singapore), the U.S.-China Joint Initiative on Avian Influenza, and the U.S.-Indonesia-Singapore Joint Avian Influenza Demonstration Project; and should develop a strategy to expand the number of countries fully cooperating with U.S. and/or international technical agencies in the fight against pandemic influenza, within 6 months. Measure of performance: finalized action plans that outline goals to be achieved and timeframes in which they will be achieved.
We have engaged in a broad range of bilateral and multilateral initiatives to build cooperation and capacity to fight pandemic influenza internationally. First and foremost is the President’s International Partnership on Avian and Pandemic Influenza, which has twice convened more than 90 countries and international organizations to further international coordination and will meet again. The Under Secretary of State for Democracy and Global Affairs represented the United States at both meetings. We continue to work through the APEC Health Task Force to develop exercises and protocols for an organized response to a pandemic. Progress also continues on the trilateral U.S.-Indonesia-Singapore Project. We have nearly completed an integrated U.S. Government strategy for bilateral and multilateral engagement with priority countries, which we will update as needed.
4.1.2.2. Complete
HHS shall staff the REDI Center in Singapore within 3 months. Measure of performance: USG staff provided to REDI Center.
Dr. Rod Hoff, formerly of the National Institute of Allergy and Infectious Diseases, within the HHS National Institutes of Health, became the Executive Director of the REDI Center in November 2006.
4.1.2.3. Complete
USDA, working with USAID and the Partnership, shall support the FAO and OIE to implement an instrument to assess priority countries’ veterinary infrastructure for prevention, surveillance, and control of animal influenza and increase veterinary rapid response capacity by supporting national capacities for animal surveillance, diagnostics, training, and containment in at-risk countries, within 9 months. Measure of performance: per the OIE’s Performance, Vision and Strategy Instrument, assessment tools exercised and results communicated to the Partnership, and priority countries are developing, or have in place, an infrastructure capable of supporting their national prevention and response plans for avian or other animal influenza.
With assistance from USDA and USAID, all priority countries are developing, and some have in place, infrastructure that can support their national prevention and response plans for animal outbreaks. OIE has evaluated infrastructure in 22 countries to identify any necessary improvements and to request appropriate resources from international donors. USDA and USAID are providing training, technical assistance, and emergency commodities to governments that need assistance.
4.1.2.4. Complete
USDA, in coordination with DOS, USAID, the OIE, and other members of the Partnership, shall support FAO to enhance the rapid detection and reporting of, response to, and control or eradication of outbreaks of avian influenza, within 12 months. Measure of performance: an international program is established and providing functional support to priority countries with rapid detection and reporting of, response to, and control or eradication of outbreaks of avian influenza, as appropriate to the country’s specific situation.
In 2005, we launched a Highly Pathogenic Avian Influenza International Coordination Group to manage rapid assessment and emergency response missions to combat avian influenza abroad and to serve as a focal point for interagency and FAO collaboration. USDA and USAID also support an international Crisis Management Center and work to ensure its coordination with WHO.
4.1.2.5. Complete
HHS, in coordination with USAID, shall increase rapid response capacity within those countries at highest risk of human exposure to animal influenza by supporting national and local government capacities for human surveillance, diagnostics, and medical care, and by supporting training and equipping of rapid response and case investigation teams for human outbreaks, within 9 months. Measure of performance: trained, deployable rapid response teams exist in countries with the highest risk of human exposure.
More than 2,000 pandemic influenza rapid response teams (RRTs) have been put in place at the national, provincial, and district levels in Asia alone. This includes the Southeast Asian countries that are at highest risk of human exposure to avian influenza: Cambodia, Indonesia, Laos, Thailand, and Vietnam. The HHS/CDC Global Disease Detection (GDD) Centers in Guatemala, Kenya, and Thailand have fully equipped, internationally mobile RRTs, and funding has been obligated to establish internationally mobile RRTs in China, Egypt, India, Indonesia, and Kazakhstan by the end of 2007. We have supported regional RRT trainings in Egypt, Indonesia, Kazakhstan, Kenya, Saudi Arabia, and Thailand.
4.1.2.7. Complete
Treasury shall encourage and support MDB programs to improve health surveillance systems, strengthen priority countries’ response to outbreaks, and boost health systems’ readiness, consistent with legislative voting requirements, within 12 months. Measure of performance: projects that fit relevant MDB criteria approved in at least 50 percent of priority countries.
With our encouragement, the world’s multilateral development banks have moved quickly to undertake programs that improve health surveillance systems, strengthen countries’ response to outbreaks, and boost health system readiness. The World Bank has pledged up to $500 million for country programs to deal with a pandemic and is administering a multi-donor trust fund. It is also playing a critical role in tracking and coordinating donor funding. The Asian Development Bank has pledged up to $470 million and is focusing on regional approaches to prevent and control pandemic influenza.
4.1.3.1. Complete
USAID, HHS, and USDA shall conduct educational programs focused on communications and social marketing campaigns in local languages to increase public awareness of risks of transmission of influenza between animals and humans, within 12 months. Measure of performance: clear and consistent messages tested in affected countries, with information communicated via a variety of media have reached broad audiences, including health care providers, veterinarians, and animal health workers, primary and secondary level educators, villagers in high-risk and affected areas, poultry industry workers, and vendors in open air markets.
We are providing technical assistance and support for communications and public education efforts in 52 countries to raise awareness, make accurate information about avian influenza readily available, and change behaviors that spread the virus. Working with government ministries, international organizations such as UNICEF, WHO, and FAO, as well as private sector groups and NGO networks, we have helped provide technical assistance, training, logistical support, and outreach materials for use at both the national and community level. Target audiences include health and veterinary workers, national and local leaders and spokespeople, the media, high-risk groups such as poultry farmers, and the general public.
4.1.3.2. Complete
HHS and USAID shall work with the WHO Secretariat and other multilateral organizations, existing bilateral programs and private sector partners to develop community- and hospital- based health prevention, promotion, and education activities in priority countries within 12 months. Measure of performance: 75 percent of priority countries are reached with mass media and community outreach programs that promote AI awareness and behavior change.
We are currently working in 89 percent of priority countries in coordination with WHO, UNICEF, and national governments to implement mass media, community-based, and hospital-based outreach programs that raise awareness of the risks of avian influenza and promote preventive behaviors. We are supporting mass media and community-based outreach activities designed to prevent outbreaks of avian influenza and reduce human exposure in 16 of these countries. We are also supporting activities for health facilities and healthcare workers in nine priority countries that include training for community-based health workers, developing clinical care guidance, and improving infection control and surveillance procedures.
4.1.4.1. Complete
DOS and HHS, in coordination with other agencies, shall ensure that the top political leadership of all affected countries understands the need for clear, effective coordinated public information strategies before and during an outbreak of avian or pandemic influenza within 12 months. Measure of performance: 50 percent of priority countries that developed outbreak communication strategies consistent with the WHO September 2004 Report detailing best practices for communicating with the public during an outbreak.
We have continually stressed the importance of transparency and outbreak communications in bilateral discussions and at global and regional forums. Working directly with affected and at-risk governments, as well as international organizations, we have both emphasized to governments the importance of developing outbreak communications strategies consistent with World Health Organization (WHO) guidelines and conducted worldwide training of health officials and journalists. To date, 11 of 19 priority countries have developed outbreak communications strategies consistent with WHO guidelines.
4.1.4.2. Complete
DOS and HHS, in coordination with other agencies, shall implement programs within 3 months to inform U.S. citizens, including businesses, NGO personnel, DOD personnel, and military family members residing and traveling abroad, where they may obtain accurate, timely information, including risk level assessments, to enable them to make informed decisions and take appropriate personal measures. Measure of performance: majority of registered U.S. citizens abroad have access to accurate and current information on influenza.
We have provided up-to-date information on avian and pandemic influenza to the majority of the more than two million Americans registered with our 260 Embassies or Consulates abroad. The U.S. Government’s official avian and pandemic influenza website -- www.pandemicflu.gov -- serves as the primary information resource for Americans residing and traveling abroad. Embassies have also hosted hundreds of ‘town hall’ meetings and other outreach events to inform Americans residing abroad. These continue and are supplemented by materials distributed in consular waiting rooms and through warden networks to Americans residing and traveling abroad. Our continued efforts aim to ensure that Americans outside the United States are informed of the risks of a pandemic and measures to take before and during an outbreak.
4.1.4.3. Complete
DOS and HHS shall ensure that adequate guidance is provided to Federal, State, tribal, and local authorities regarding the inviolability of diplomatic personnel and facilities and shall work with such authorities to develop methods of obtaining voluntary cooperation from the foreign diplomatic community within the United States consistent with USG treaty obligations within 6 months. Measure of performance: briefing materials and an action plan in place for engaging with relevant Federal, State, tribal and local authorities.
A plan to provide guidance to the foreign diplomatic community has been developed and implemented. The website of the State Department’s Office of Foreign Missions has been designated as the forum for communications with the foreign diplomatic community, which has already been briefed extensively on pandemic preparedness by the Under Secretary of State for Democracy and Global Affairs and other senior officials. We have also developed a plan for quickly disseminating guidance to State, local, and tribal authorities through the national organizations representing these governmental entities and directly to the governors’ and tribal leaders’ offices. Guidance for State, local, and tribal authorities has been provided as part of ongoing training exercises conducted by DHS.
4.1.4.4. Complete
USAID, USDA, and HHS shall work with the WHO Secretariat, FAO, OIE, and other donor countries within 12 months to implement a communications program to support government authorities and private and multilateral organizations in at-risk countries in improving their national communications systems with the goal of promoting behaviors that will minimize human exposure and prevent further spread of influenza in animal populations. Measure of performance: 50 percent of priority countries have improved national avian influenza communications.
With support from the U.S. Government, national communications efforts have been strengthened in 84 percent of priority countries through activities that build national communications capacity and stress awareness campaigns to promote changes in behavior. We are working with host governments and international organizations – including WHO, FAO, OIE, and UNICEF – as well as other donors and the private sector to provide both technical and operational support for such activities. We have supported the training of nearly 114,000 people -- including 102,764 people in priority countries -- to deliver messages about the hazards of avian influenza to poultry farmers and the general public.
4.1.4.5. Complete
USAID, in coordination with DOS, HHS, and USDA, shall develop and disseminate influenza information to priority countries through international broadcasting channels, including international USG mechanisms such as Voice of America and Radio Free Asia (radio, television, shortwave, internet), and share lessons learned and key messages from communications campaigns, within 12 months. Measure of performance: local language briefing materials and training programs developed and distributed via WHO and FAO channels. USAID and HHS are conducting communications activities in 52 countries in coordination with DOS and USDA, and have developed materials in four world languages (English, French, Spanish and Portuguese) as well as local languages, including both print and broadcast media.
We are using a wide variety of channels and media to disseminate key messages for preventing avian influenza and behavior change. Our partners include WHO, FAO, and UNICEF; international broadcasting networks such as the Voice of America; national media and government ministries; and non-governmental organizations such as the Red Cross and Veterinarians Without Borders (AVSF).
4.1.5.1. Complete
DOS, in coordination with other agencies, shall use the Partnership and bilateral and multilateral diplomatic contacts on a continuing basis to encourage nations to increase international production capacity and stockpiles of safe and effective human vaccines, antiviral medications, and medical material within 12 months. Measure of performance: increase by 50 percent the number of priority countries that have plans to increase production capacity and/or stockpiles.
We assisted WHO in producing a global pandemic influenza action plan to increase vaccine supply in selected developing nations and have given $10 million in support of this plan. In April 2007, WHO announced that Brazil, India, Indonesia, Mexico, Thailand, and Vietnam would each receive up to $2.5 million to develop influenza vaccine production facilities. Reports indicate that most priority countries have taken steps to establish stockpiles of antiviral, and most have plans to produce or acquire pre-pandemic vaccine. Virtually all priority countries have stockpiled personal protective equipment.
4.1.5.2. Complete
HHS and USAID shall work to coordinate and set up emergency stockpiles of protective equipment and essential commodities other than vaccine and antiviral medications for responding to animal or human outbreaks within 9 months. Measure of performance: essential commodities procured and available for deployment within 24 hours.
USAID developed an international stockpile of essential non-pharmaceutical commodities – including personal protective equipment (PPE), decontamination equipment, and equipment for safely collecting and shipping human samples of H5N1 – which are available for international deployment within 24 hours. USAID has procured a total of 1.5 million kits of personal protective equipment, 15,000 decontamination kits, and 100 lab specimen collection kits, and has deployed equipment to support avian influenza surveillance and response in more than 71 countries. Stockpiles of protective equipment are also available and can be deployed within 24 hours from U.S. Global Disease Detection Centers in Guatemala, Kenya, and Thailand, and from the CDC Office in South Africa, for use during the initial wave of the response to an outbreak of human disease.
4.1.5.3. Complete
HHS shall provide technical expertise, information, and guidelines for stockpiling and use of pandemic influenza vaccines within 6 months. Measure of performance: all priority countries and partner organizations have received relevant information on influenza vaccines and application strategies.
We have developed and produced materials on pandemic influenza vaccine strategies and capacity building that contain staff contact information and relevant FDA and WHO website links related to vaccine production and licensing. This package was disseminated to all 18 State Department-designated pandemic influenza focus countries. The package was also sent to WHO Headquarters and distributed to GHSAG (Global Health Security Action Group) countries.
4.1.5.4. Complete
USDA and USAID, in cooperation with FAO and OIE, shall provide technical expertise, information and guidelines for stockpiling and use of animal vaccines, especially to avian influenza affected countries and those countries at highest risk, within 6 months. Measure of performance: all priority countries and relevant international organizations have received information on animal vaccines’ efficacy and application strategies to guide country-specific decisions about preparedness options.
U.S. Embassies and missions have ensured that all priority countries have received international guidance on the use of animal vaccines. We are also working with academic institutions to produce a training program on the use of animal vaccines and vaccination strategies and are providing support for an international scientific conference in March 2007 on avian influenza vaccination standards, trade implications, strategies for implementation, and experiences to date.
4.1.6.3. Complete
USDA shall generate new information on avian vaccine efficacy and production technologies and disseminate to international organizations, animal vaccine manufacturers, and countries at highest risk within 6 months. Measure of performance: information disseminated to priority entities.
We have distributed information on avian influenza vaccines and vaccination to the two primary international animal health organizations (FAO and OIE) to multiple national and international animal health industry and trade associations and to representatives of international vaccine manufacturers. USDA scientists have presented information at international conferences and symposia, as well as to governments and poultry industries in key priority and at-risk countries. Video training modules have also been developed and will be distributed in FY 2007 to countries in Africa, Asia, and Central and South America. We will continue to disseminate vaccine efficacy information as new experiments are designed, implemented, and completed.
4.1.7.1. Complete
DOS shall work with HHS and USAID, in collaboration with the WHO Secretariat, to coordinate the USG contribution to an international stockpile of antiviral medications and other medical countermeasures, including international countermeasure distribution plans and mechanisms and agreed prioritization of allocation, within 6 months. Measure of performance: release of proposed doctrine of deployment and concept of operations for an international stockpile.
We have formulated a policy on our contribution to international stockpiles, as well as for the deployment and use of antiviral medications, that will serve as guidance for the distribution and allocation of supplies. The United States has also forward deployed antiviral assets from the Strategic National Stockpile overseas to assist with international containment efforts. The U.S. Government is coordinating with the World Health Organization, which is at present reviewing this strategy, which will enable us to direct and apply limited resources in an effective manner.
4.1.7.2. Complete
The Department of Justice (DOJ) and DOS, in coordination with HHS, shall consider whether the USG, in order to benefit from the protections of the Defense Appropriations Act, should seek to negotiate liability-limiting treaties or arrangements covering U.S. contributions to an international stockpile of vaccine and other medical countermeasures, within 6 months. Measure of performance: review initiated and decision rendered.
State and DOJ previously conducted two reviews to consider whether the United States should seek to negotiate liability-limiting treaties or arrangements covering U.S. contributions to an international stockpile of vaccines. We have conducted a third review and continue to find there is no compelling need to seek such arrangements. With input from HHS, State, and DOJ continue to monitor relevant factors that could warrant a change in finding.
4.1.7.3. Complete
USDA, in collaboration with FAO and OIE, shall develop and provide best-practice guidelines and technical expertise to countries that express interest in obtaining aid in the implementation of a national animal vaccination program, within 4 months. Measure of performance: interested countries receive guidelines and other assistance within 3 months of their request.
We have worked with FAO and OIE to develop and deliver best practice guidelines and technical expertise to interested countries in a number of ways. For example, we helped develop the FAO Global Strategy for progressive AI eradication and an OIE technical manuscript on emergency management. Through USDA funding, representatives from all priority countries were able to attend a vaccination seminar hosted by FAO/OIE. We also collaborated with Iowa State University to produce a multimedia training module on animal vaccines and vaccination strategies. USDA has met all requests for assistance with experts or training courses to address the various concerns.
4.1.8.2. Complete
HHS shall enhance a regional influenza genome reference laboratory in Singapore within 9 months. Measure of performance: capacity to sequence complete influenza virus genome established in Singapore; all reported novel animal influenza samples sequenced and made available on public databases.
The Genomics Institute of Singapore is now fully staffed and equipped to sequence and characterize viral genomes. The institute is working with partners in Vietnam and Indonesia to isolate and sequence the causative agents of viral pneumonias, including avian influenza. Sequences of special scientific interest will be published in a peer-reviewed journal; complete sequences will be submitted to GenBank.
4.1.8.3. Complete
USDA and USAID shall work with international organizations, governments, and scientific entities to disseminate and exchange information to bolster and apply avian influenza prevention and response plans in priority countries, within 12 months. Measure of performance: 50 percent of priority countries have national epizootic prevention and response plans based upon pragmatic, comprehensive, and scientifically valid information.
All priority countries currently have national epizootic prevention and response plans. USAID and USDA are working with more than 40 countries to improve national and local planning efforts, conduct simulations and trainings for national officials and responders, increase the availability of scientific information about H5N1 through better surveillance and greater international cooperation and transparency, and provide commodities for outbreak preparedness and response.
4.1.8.4. Complete
HHS and DOD, in coordination with DOS, shall enhance open source information sharing efforts with international organizations and agencies to facilitate the characterization of genetic sequences of circulating strains of novel influenza viruses within 12 months. Measure of performance: publication of all reported novel influenza viruses which are sequenced.
We are working with domestic and international partners to characterize genetic sequences of new influenza viruses. Last summer, we submitted more than 650 sequences of various influenza viruses to the National Center for Biotechnology Information (NCBI) of the NIH National Library of Medicine for inclusion in GenBank, a publicly available, searchable database (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Nucleotide).
4.2.1.1. Complete
DOS, in coordination with other agencies, shall work on a continuing basis through the Partnership and through bilateral and multilateral diplomatic contacts to promote transparency, scientific cooperation, and rapid reporting of avian and human influenza cases by other nations within 12 months. Measure of performance: all high-risk countries actively cooperating in improving capacity for transparent, rapid reporting of outbreaks.
Transparency and rapid reporting are core principles of the International Partnership on Avian and Pandemic Influenza (IPAPI) and were highlighted formally and with the press at the major IPAPI conferences in Washington, D.C., and Vienna and at an affiliated international meeting in Bamako, Mali. This message is conveyed in nearly every discussion with bilateral and multilateral partners. We continue to work with at least 70 nations, including high-risk countries, where there is greatest risk from avian influenza and where there are manifest constraints to detecting and reporting outbreaks. Countries continue to strengthen their capacity to respond to and report on outbreaks.
4.2.1.2. Complete
HHS, in coordination with DOS, shall, to the extent feasible, negotiate bilateral agreements with key affected countries on health cooperation including transparency, sample and data sharing, and development of rapid response protocols; and develop and train in-country rapid response teams to quickly assess and report on possible outbreaks of avian and human influenza, within 12 months. Measure of performance: agreements established with Vietnam, Cambodia, and Laos, 100 teams throughout Asia, including China, Thailand, and Indonesia, trained and available to respond to outbreaks.
More than 2,000 internationally mobile rapid response teams (RRTs) have been established at the district, provincial, and national levels throughout Asia. There are more than 1,000 RRTs each in Thailand and Vietnam, as well as RRTs in most provinces, states, or districts of Bangladesh, Cambodia, India, Indonesia, and Laos. Fully equipped RRTs are ready for action at the GDD Center in Bangkok, and an RRT will be in place at the Indonesian Center for Disease Control by the end of 2007. Bilateral agreements on health cooperation have been established with the Governments of Cambodia and Vietnam, and U.S. Government support for collaborative activities with Laos is provided via a cooperative agreement with WHO regional offices.
4.2.1.3. Complete
HHS shall place long-term staff at key WHO offices and in select affected, high-risk, and at-risk countries to provide coordination of HHS-sponsored activities and to serve as liaisons with HHS within 9 months. Measure of performance: placement of staff and increased coordination with the WHO Secretariat and Regional Offices.
HHS has placed long-term staff in Cambodia, China, Egypt, Indonesia, Kazakhstan, Laos, Peru, Thailand, and Vietnam to coordinate activities and technical assistance. Additionally, HHS has increased coordination capacity globally by placing staff at WHO headquarters and at its regional offices in the Republic of Congo, India, and the Philippines.
4.2.1.4. Complete
HHS shall, to the extent feasible, negotiate agreements with established networks of laboratories around the world to enhance its ability to perform laboratory analysis of human and animal virus isolates and to train in-country government staff on influenza-related surveillance and laboratory diagnostics, within 6 months. Measure of performance: completed, negotiated agreement, and financing mechanism with at least one laboratory network outside the United States.
Agreements with Institut Pasteur and the Gorgas Institute have been developed, including $1,550,066 obligated to Institut Pasteur and $775,000 to the Gorgas Institute for projects that focus on laboratory analysis and training.
4.2.1.5. Complete
HHS shall support the WHO Secretariat to enhance the early detection, identification and reporting of infectious disease outbreaks through the WHO’s Influenza Network and Global Outbreak and Alert Response Network (GOARN) within 12 months. Measure of performance: expansion of the network to regions not currently part of the network.
We are supporting WHO activities that improve global disease surveillance and response. They include: enhancement and expansion of the WHO Global Influenza Surveillance Network and the Global Outbreak Alert and Response Network; support for a joint response protocol for animal outbreaks with FAO’s Crisis Management Center; expansion of Global Disease Detection (GDD) Centers’ networks; and assistance for Field Epidemiology Training Programs (FETPs) and Field Epidemiology and Laboratory Training Programs (FELTPs) in many countries. Two new FELTPs—in Pakistan and South Africa—were established in 2006 and planning is under way to establish new FETPs in Cambodia and Vietnam. Collectively, these efforts have improved early detection, identification, and reporting of cases or outbreaks of pandemic influenza throughout the world.
4.2.1.6. Complete
USAID, in coordination with USDA, shall initiate a pilot program to evaluate strategies for farmer compensation and shall engage and leverage the private sector and other donors to increase the availability of key commodities, compensation, financing and technical support for the control of avian influenza within 6 months. Measure of performance: a model compensation program measured in value of goods and services available for compensation is developed.
To address the challenging issue of compensation, we have developed a replicable compensation model in partnership with the World Bank, FAO, and the Government of Indonesia. This program will be launched in early 2007and will integrate compensation into ongoing community-based surveillance and response efforts. We are also working with international organizations such as the World Bank to research and recommend compensation strategies, including non-monetary incentives, and to develop approaches to indemnity programs that could be used in other priority and high-risk countries.
4.2.1.7 Complete
USAID, HHS, USDA, and DOS shall support NGOs, FAO, OIE, WHO, the Office of the Senior UN System Coordinator for Avian and Human Influenza, and host governments to expand the scope, accuracy, and transparency of human and animal surveillance systems and to streamline and strengthen official protocols for reporting avian influenza cases, within 6 months. Measure of performance: 75 percent of priority countries have established early warning networks, international case definitions, and standards for laboratory diagnostics of human and animal samples.
All priority countries have established early-warning networks for H5N1 in animals and conform to disease definitions and diagnostic standards for influenza established by the World Organization for Animal Health. More than 75 percent of priority countries have human influenza early-warning capabilities and all abide by international case definitions; more than 75 percent have laboratories that meet standards for human diagnosis. We have provided technical assistance to strengthen national surveillance systems in all priority countries, support to international organizations for human and animal health to promote early warning surveillance for influenza outbreaks in affected countries, and technical training to strengthen human and animal diagnostic laboratories in the detection of influenza virus in priority countries.
4.2.2.1. Complete
HHS and USDA, in collaboration with one or more established networks of laboratories around the world, including the WHO Influenza Network, shall train staff from priority countries’ Ministries of Health and Agriculture to conduct surveillance and perform epidemiologic analyses on influenza-susceptible species and manage and report results of findings, within 12 months. Measure of performance: 75 percent of priority countries have access to multi-year epidemiology and surveillance training programs.
USDA training activities are complemented by HHS/CDC public health training efforts, which include regional Train-the-Trainer Rapid Response Team (RRT) workshops on applied epidemiology and post-event disease surveillance for avian and pandemic influenza. Master trainers who complete the regional RRT workshops train provincial-level responders, who in turn train district-level responders. Additional RRT workshops have been conducted or are planned for 2007 worldwide.
4.2.2.2. Complete
HHS and USDA shall increase support of scientists tracking potential emergent influenza strains through disease and virologic surveillance in susceptible animal species in priority countries within 9 months. Measure of performance: surveillance for emergent influenza strains expanded in priority countries.
We have expanded surveillance for emerging influenza strains in priority countries. Our efforts include: collecting and analyzing influenza viruses from animals in high-risk Asian countries; conducting North American surveillance with Canada and Mexico; supporting the USAID-sponsored Wild Bird Surveillance project in eight priority countries; expediting rapid characterization and publication of viral sequences via the NIH Influenza Genome Sequencing Project; and awarding research funds to study evolving influenza viruses. USDA is collaborating with other countries on avian influenza-related research, providing training, and helping to collect and transport field specimens to diagnostic laboratories.
4.2.2.3. Complete
HHS, in coordination with DOD, shall provide support to Naval Medical Research Unit (NAMRU) 2 in Jakarta, Indonesia and Phnom Penh, Cambodia, the Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand, and NAMRU-3 in Cairo, Egypt to expand and expedite geographic surveillance of human populations at-risk for H5N1 infections in those and neighboring countries through training, enhanced surveillance, and enhancement of the Early Warning Outbreak Recognition System, within 12 months. Measure of performance: reagents and technical assistance provided to countries in the network to improve and expand surveillance of H5N1 and number of specimens tested by real-time processing.
U.S. Naval Medical Research Units 2 and 3 (NAMRU-2 and NAMRU-3), supported by funding from HHS/CDC, are providing influenza-related diagnostic assistance to 29 countries in Africa, Asia, Europe, and the Middle East. The number of influenza specimens submitted to HHS/CDC has increased significantly: from 615 in 2005 to 754 in 2006 (NAMRU-2) and 90 in 2005 to 423 in 2006 (NAMRU-3).
4.2.2.4. Complete
HHS shall enhance surveillance and response to high priority infectious disease, including influenza with pandemic potential, by training physicians and public health workers in disease surveillance, applied epidemiology and outbreak response at its GDD Response Centers in Thailand and China and at the U.S.-China Collaborative Program on Emerging and Re-Emerging Infectious Diseases, within 12 months. Measure of performance: 50 physicians and public health workers living in priority countries receive training in disease surveillance applied epidemiology and outbreak response.
More than 250 public health workers from priority countries have been trained in disease surveillance, field epidemiology, and outbreak response. Physicians in Cambodia, Laos, and Vietnam are also receiving hospital-based training in infection control and/or case management during an influenza pandemic.
4.2.3.1. Complete
HHS shall develop and implement laboratory diagnostics training programs in basic laboratory techniques related to influenza sample preparation and diagnostics in priority countries within 9 months. Measure of performance: 25 laboratory scientists trained in influenza sample preparation and diagnostics.
More than 40 laboratory scientists in priority countries have been trained in influenza sample preparation and molecular diagnostics at regional laboratory workshops in Thailand and Uganda, at the CDC in Atlanta, or in country at national public health laboratories.
4.2.3.2. Complete
HHS in collaboration with one or more established networks of laboratories, including the WHO Influenza Network, shall train staff from priority countries on influenza-related laboratory diagnostics, within 12 months. Measure of performance: 100 percent of priority countries have training programs established.
All priority countries have access to established diagnostics training programs, including hands-on trainings at WHO National Influenza Centers, regional laboratory workshops coordinated by HHS/CDC, training programs at DOD laboratories, and USAID-supported courses on sample collection, use of rapid diagnostics for human and animal samples, and international sample-shipping procedures. In addition, all priority countries have been provided with resources and technical assistance for developing and enhancing influenza-related laboratory diagnostic capacity. HHS/CDC continues to provide training to ensure that laboratory staff can perform rapid influenza-related diagnosis in priority countries.
4.2.3.3. Complete
HHS, in cooperation with the WHO Secretariat and other donor countries, shall expand an existing specimen transport fund that enables developing countries to transport influenza samples to WHO regional reference laboratories and collaborating centers, within 6 months. Measure of performance: 100 percent of priority countries funded for sending influenza samples to WHO regional reference laboratories.
To ensure that all priority countries have the ability to rapidly transport influenza samples to WHO for analysis, we have provided $400,000 to WHO to conduct five training workshops focused on proper transport of dangerous materials, as well as to provide consultations with priority African partners regarding the proper protocol for specimen transport.
4.2.3.5. Complete
HHS and USAID shall work with the WHO Secretariat and private sector partners, through existing bilateral agreements, to provide support for human health diagnostic laboratories by developing and giving assistance in implementing rapid international laboratory diagnostics protocols and standards in priority countries, within 12 months. Measure of performance: 75 percent of priority countries have improved human diagnostic laboratory capacity.
In coordination with WHO, private sector and non-governmental partners, we have helped all priority countries improve diagnostic protocols, upgrade laboratories, and reduce the amount of time required to diagnose H5N1. We have also provided direct technical assistance or equipment for laboratories in 13 of 19 priority countries and emergency sample collection and shipping kits to eight priority countries, in addition to supporting training in human surveillance for more than 15,000 people.
4.2.3.6. Complete
USDA and USAID shall work with FAO and OIE to provide technical support for animal health diagnostic laboratories by developing and implementing international laboratory diagnostic protocols, standards, and infrastructure in priority countries that can rapidly screen avian influenza specimens from susceptible animal populations, within 12 months. Measure of performance: 75 percent of priority countries have improved animal diagnostic laboratory capacity.
We have helped 95 percent of priority countries improve their capacity for surveillance and laboratory diagnosis through training, technical assistance, and the provision of commodities (such as protective gear) and rapid diagnostic materials. We are also working with FAO and other international partners to implement surveillance protocols, increase access to international reference laboratories, and strengthen national laboratories.
4.2.3.7. Complete
USDA and USAID shall provide technical expertise to help priority countries develop their cadre of veterinary diagnostic technicians to screen avian influenza specimens from wild and domestic bird populations, and other susceptible animals, rapidly and in a manner that adheres to international standards for proficiency and safety, within 12 months. Measure of performance: all priority countries have access to laboratories that are able to screen avian influenza specimens and confirm diagnoses in a manner that supports effective control of cases of avian influenza.
All priority countries now have access to laboratory diagnostic capacity for avian influenza either through national laboratories or through regional reference laboratories. USAID and USDA have provided assistance to virtually all priority countries to improve animal surveillance and early warning and to ensure access to laboratory diagnosis. In addition, we have entered into bilateral agreements with Cambodia, China, and Mexico to assist in training and in carrying out wild bird surveillance. We are developing agreements with Brazil, Greenland and Russia.
4.2.5.1. In progress
HHS and USAID shall develop, in coordination with the WHO Secretariat and other donor countries, rapid response protocols for use in responding quickly to credible reports of human-to-human transmission that may indicate the beginnings of an influenza pandemic, within 12 months. Measure of performance: adoption of protocols by WHO and other stakeholders.
With our input and support, WHO has released a revised and updated version of rapid response and containment protocols for review by stakeholders. We participated in developing protocols and guidelines for the use and coordination of international antiviral stockpiles to be used for containment. USAID is supporting the work of WHO and FAO to develop coordinated protocols for responding to avian influenza outbreaks and assisted in developing a UN Pandemic Preparedness and Humanitarian Response Plan.
4.2.5.2. In progress
HHS, in coordination with DOS and other agencies participating in the Security and Prosperity Partnership, shall pursue cooperative agreements on pandemic influenza with Canada and Mexico to create and implement a North American early warning surveillance and response system in order to prevent the spread of infectious disease across the borders, within 9 months. Measure of performance: implementation of early warning surveillance and response system.
Under the auspices of the Security and Prosperity Partnership of North America, the United States, Mexico, and Canada have drafted the North America Plan for Avian and Pandemic Influenza. This plan outlines how we will work together to combat an outbreak of avian or pandemic influenza in North America. A Laboratory and Surveillance Technical Working Group will provide technical support for addressing laboratory, surveillance, and epidemiological issues related to pandemic influenza. In addition to SPP efforts, HHS uses collaborative relationships, technical assistance, and funding through grants and cooperative agreements to help improve the North American countries’ ability to detect new influenza stains and rapidly communicate critical information to their neighbors.
4.2.5.3. Complete
USDA and USAID shall provide technical expertise to priority countries in order to expand the scope and accuracy of systematic surveillance of avian influenza cases, within 12 months. Measure of performance: 75 percent of priority countries have expanded animal surveillance capabilities.
All priority countries have expanded their animal surveillance capabilities. We have provided assistance for improving animal surveillance and diagnostic capacity, including early warning networks, in 95 percent of these countries through training, technical assistance, logistical support and equipment, and grants, including support to WHO and FAO. With our support, more than 50,000 people have been trained in animal surveillance and nearly 18,000 in human surveillance. Approximately 129,000 people have been trained to respond to poultry outbreaks and 17,000 to human outbreaks. Nearly 114,000 people – including journalists – have been trained to deliver AI messages to poultry workers and the general public.
4.2.6.1. Complete
DHS, USDA, DOI, and USAID, in collaboration with priority countries, NGOs, WHO, FAO, OIE, and the private sector shall support priority country animal health activities, including development of regulations and enforcement capacities that conform to OIE standards for transboundary movement of animals, development of effective biosecurity measures for commercial and domestic animal operations and markets, and identification and confirmation of infected animals, within 12 months. Measure of performance: 50 percent of priority countries have implemented animal health activities as defined above.
All priority countries have implemented animal health activities to improve biosecurity measures and the identification of infected animals. USDA, DOI, and USAID are supporting animal health activities related to avian influenza prevention, surveillance and diagnosis, and containment measures in 95 percent of priority countries through training, technical assistance, and financial and logistical support. We also helped to create the Global Avian Influenza Network for Surveillance to monitor avian influenza in wild birds, track genetic changes in virus isolates, and increase transparency of disease information.
4.2.7.1. Complete
DOS, in coordination with DOT, DHS, HHS, and U.S. Trade Representative (USTR), shall collaborate with WHO, the International Civil Aviation Organization (ICAO), and the International Maritime Organization (IMO) to assess and revise, as necessary and feasible, existing international agreements and regulations governing the movement and shipping of potentially infectious products, in order to ensure that international agreements are both adequate and legally sufficient to prevent the spread of infectious disease, within 12 months. Measure of performance: international regulations reviewed and revised.
We have reviewed existing international regulations and agreements governing the movement and shipping of potentially infectious products and have concluded that there is no need to revise them at this time. We believe that the current regimen is both adequate and legally sufficient to prevent the spread of infectious disease.
4.2.8.1. Complete
HHS and USAID shall develop community- and hospital-based infection control and prevention, health promotion and education activities in local languages in priority countries within 9 months. Measure of performance: local language health promotion campaigns and improved hospital-based infection control activities established in all South East Asian priority countries.
Working with UN technical agencies, national governments, and other international partners, we are supporting health promotion campaigns, hospital and health facility-based infection control activities, and public health communications planning and training in all Southeast Asia priority countries. In Cambodia, Indonesia, Laos, and Vietnam we have helped train more than 70,500 people -- including journalists -- in delivering prevention messages, and nearly 114,000 people worldwide. We have also helped develop communications materials and messages aimed at the general public and health workers.
4.3.1.2 Complete
DOS, in coordination with HHS, shall work with WHO and the international community to secure agreement (e.g., through a resolution at the World Health Assembly in May 2006) on an international containment strategy to be activated in the event of a human outbreak, including an accepted definition of a “triggering event” and an agreed doctrine for coordinated international action, responsibilities of nations, and steps they will take, within 4 months. Measure of performance: international agreement on a response and containment strategy.
WHO issued its “Rapid Operations to Contain the Initial Emergence of Pandemic Influenza” protocol in May 2007. The United States provided significant technical input to this protocol, which outlines a framework for ‘triggering’ actions. We have also implemented numerous efforts to build response and containment capacity in at-risk countries and to reinforce broad acceptance of the International Health Regulations and related WHO protocols and standards. We are finalizing protocols for the United States on responses to and containment of outbreaks and have developed a curriculum to teach principles of rapid pandemic response to public health personnel in other countries.
4.3.1.6. Complete
DOS shall lead USG engagement with the international community’s effort to develop a coordinated plan for avian influenza assistance (funds, materiel, and personnel) to streamline national assistance efforts within 12 months. Measure of performance: commitments from countries on funds, personnel, and materiel they will contribute to an integrated and prioritized international prevention, preparedness, and response effort.
Global pledges of assistance to avian and pandemic preparedness currently total approximately $2.3 billion. Of that amount, the cumulative U.S. pledge of $434 million is the largest single commitment to building cooperation and capacity to fight avian influenza and promote pandemic preparedness internationally. We continue to work closely with the United Nations and World Bank to lead the international promotion of harmonized and synchronized donor mechanisms to facilitate maximum flexibility to adjust to changes in the global avian influenza and pandemic preparedness situation and help sustain commitments from countries on funds.
4.3.1.7. Complete
DOS, in coordination with and drawing on the expertise of USAID, HHS, and DOD, shall work with the international community to develop, within 12 months, a coordinated, integrated, and prioritized distribution plan for pandemic influenza assistance that details a strategy for (1) strategic lift of WHO stockpiles and response teams, (2) theater distribution to high-risk countries, (3) in-country coordination to key distribution areas, and (4) establishment of internal mechanisms within each country for distribution to urban, rural, and remote populations. Measure of performance: commitments by countries that specify their ability to support distribution, and specify the personnel and material for such support.
We are actively supporting the central role of WHO and the UN system in leading international, regional, and country preparations for a possible global influenza pandemic. WHO has issued pandemic preparedness guidance, including information regarding in-country coordination and logistics, and reports that 178 nations now have national plans. We participated in the development of protocols and guidelines for the use and coordination of international antiviral stockpiles prepositioned by WHO. The United States also has prepositioned stockpiles of antiviral medications and essential non-pharmaceutical commodities.
4.3.1.8. Complete
DOS, in coordination with HHS, USDA, USAID, and DHS, and in collaboration with WHO, FAO, OIE, the World Bank and regional institutions such as APEC, the Association of Southeast Asian Nations and the European Community, shall, to the extent feasible, improve public affairs coordination and establish a set of agreed upon operating principles among these international organizations and the United States that describe the actions and expectations of the public affairs strategies of these entities that would be implemented in the event of a pandemic, within 6 months. Measure of performance: list of key public affairs contacts developed, planning documents shared, and coordinated public affairs strategy developed.
With our assistance, WHO has issued communication and public affairs guidelines that have been shared with public affairs contacts throughout the UN system, OIE, the World Bank, and regional organizations. We provided a public affairs network and contact list, as well as a reference to U.S. planning documents posted on www.pandemicflu.gov, and are working with WHO to expand and update the network.
4.3.1.9 Complete
DOS and DOC, in collaboration with NGOs and private sector groups representing business with activities abroad, shall develop and disseminate checklists of key activities to prepare for and respond to a pandemic, within 6 months. Measure of performance: checklists developed and disseminated.
State and DOC, in collaboration with the CDC, have compiled a checklist entitled “Pandemic Preparedness Planning for U.S. Businesses with Overseas Operations,” which has been disseminated via the pandemicflu.gov website and through trade associations for use by a wide range of non-governmental and private sector organizations. The International Trade Administration at (DOC), in conjunction with the Bureau of East Asian Affairs and the Office of Economic Policy at State, developed informational guidance for small/medium businesses targeting APEC economies. The guidance has been placed on the APEC website for use by all APEC member economies, but primarily for those APEC members that do not have robust pandemic preparedness plans.
4.3.2.2. Complete
DOD, in coordination with DOS, HHS, DOT, and DHS, will limit official DOD military travel between affected areas and the United States. Measure of performance: DOD identifies military facilities in the United States and OCONUS that will serve as the points of entry for all official travelers from affected areas, within 6 months.
DOD is prepared to support the National Strategy for Pandemic Influenza Implementation Plan throughout the phases of a pandemic. We will assess the restricted/modified movement of our agency personnel to designated points of entry. These restrictions and/or modifications will limit the potential spread of influenza by enabling proper medical screening and in some cases isolation and quarantine of personnel traveling to/from affected areas. Further assessments of logistics, medical support, and host nation coordination continue.
4.3.4.1. Complete
DOS in collaboration with the Partnership and WHO shall negotiate international instruments and/or arrangements to facilitate the flow of rapid response teams and other public health, medical, and veterinary personnel across international borders, within 12 months. Measure of performance: negotiated agreements for facilitating deployment of rapid response teams deployed across international borders using instruments and/or arrangements as detailed above, within 48 hours of request.
We have consulted within the U.S. Government and with multilateral organizations such as FAO, WHO, and the International Partnership on Avian and Pandemic Influenza to facilitate the flow of rapid response teams. The Department of State has officially contacted all foreign missions in Washington to establish prompt cooperation in granting visas to U.S. avian and pandemic influenza emergency response personnel. The USAID Office of Foreign Disaster Assistance and the CDC both report good foreign mission cooperation in granting of visas – generally within 24 hours. FAO is actively assessing its pre-deployment arrangements, including visa procurement for response teams, to improve efficiency.
4.3.5.1. Complete
DOS shall organize an interagency group to analyze the potential economic and social impact of a pandemic on the stability and security of the international community, within 3 months. Measure of performance: issues identified and policy recommendations prepared.
We have formed an interagency group to examine the potential global economic impact of a pandemic. The group has addressed a preliminary set of issues and has formulated policy recommendations. It has also succeeded in identifying border policies with the aim of preventing the arrival of a pandemic in the United States. Our efforts will help us to weigh the economic implications and costs of various policy alternatives.
4.3.5.2. Complete
Treasury shall urge the IMF to enhance its surveillance of priority countries and regions, including further assessment of the macroeconomic and financial vulnerability to an influenza pandemic, within 3 months. Measure of performance: updated, expanded IMF analysis of the potential impact of an influenza pandemic on priority countries and regions, as defined above.
In collaboration with the IMF and the multilateral development banks, we plan to ensure that financial assistance to affected economies is provided on terms consistent with the goals of restoring economic activity and maximizing economic growth (within existing international financial agreements). The IMF stands ready to help address countries’ balance of payments needs in response to a pandemic. The World Bank is tracking donor commitments for avian influenza programs and the Asian Development Bank is taking the lead in coordinating donor actions in Asia.
4.3.5.3. Complete
Treasury, in collaboration with the IMF and the multilateral development banks, shall take the lead on dialogue with creditor countries to ensure that financial assistance to affected economies is provided on terms consistent with the goals of restoring economic activity and maximizing economic growth (within existing international financial agreements), within 6 months. Measure of performance: official financing strategies in place that are consistent with the goals above.
International donors have endorsed the multi-donor framework for pandemic influenza developed by the World Bank, which calls for a flexible financing approach to take account of different kinds of contributions (cash, grants, loans, or in-kind) and donor procedures, consistent with the goals of minimizing economic disruptions and maintaining growth. The World Bank is monitoring donor disbursements to help ensure consistency with the framework. The Asian Development Bank is taking the lead in coordinating donor activities in the Asia and Pacific region. The IMF stands ready to meet members’ balance of payments needs arising from a pandemic using existing facilities, including stand-by arrangements or emergency assistance.
4.3.6.1. Complete
DOS, in coordination with HHS, USAID, USDA, DOD, and DHS, shall lead an interagency public diplomacy group to develop a coordinated, integrated, and prioritized plan to communicate U.S. foreign policy objectives relating to our international engagement on avian and pandemic influenza to key stakeholders (e.g., the American people, the foreign public, NGOs, international businesses), within 3 months. Measure of performance: number and range of target audiences reached with core public affairs and public diplomacy messages, and impact of these messages on public responses to avian and pandemic influenza.
Information on pandemic preparedness and U.S. international policy and activities for broad domestic and international audiences has been posted on U.S. Government websites, including www.pandemicflu.gov, www.state.gov/g/avianflu, and www.usinfo.state.gov. Key U.S. officials have also reached out to the American public through speeches in public forums. Through international media orientation, TV documentaries, websites, news stories, and enhanced Voice of America broadcasting, we have reached an estimated audience of more than 300 million persons.
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5.1.1.2 Complete
HHS and DHS, in coordination with the National Economic Council (NEC), DOD, DOC, U.S. Trade Representative (USTR), DOT, DOS, USDA, Treasury, and key transportation and border stakeholders, shall establish an interagency modeling group to examine the effects of transportation and border decisions on delaying spread of a pandemic, and the associated health benefits, the societal and economic consequences, and the international implications, within 6 months. Measure of performance: interagency working group established, planning assumptions developed, priorities established, and recommendations made on which models are best suited to address priorities.
We are fully engaged with an interagency working group to discuss modeling and economic analysis issues, establish Federal priorities, develop an inventory of modeling capabilities for each priority, and recommend which priorities should be modeled. We evaluated a wide range of modeling and simulation tools, to support analysis of the health, economic and international impacts of a pandemic. We developed initial planning assumptions (e.g., morbidity, mortality, absenteeism) that are included in department pandemic influenza plans.
5.1.1.3. Complete
DHS and DOT, in coordination with DOD, HHS, USDA, Department of Justice (DOJ), and DOS, shall assess their ability to maintain critical Federal transportation and border services (e.g., sustain National Air Space, secure the borders) during a pandemic, revise contingency plans, and conduct exercises, within 12 months. Measure of performance: revised contingency plans in place at specified Federal agencies that respond to both international and domestic outbreaks and at least two interagency exercises carried out to test the plans.
We have developed pandemic contingency plans to ensure their ability to secure borders and sustain the National Airspace system. Agencies within DOT and DHS have conducted nearly a dozen internal exercises of those plans, as well as an interagency exercise.
5.1.2.1. Complete
DHS and HHS, in coordination with DOT and USDA, shall review existing grants or Federal funding that could be used to support transportation and border-related pandemic planning, within 4 months. Measure of performance: all State, local, and tribal governments are in receipt of, or have access to, guidance for grant applications.
All eligible entities have received program guidance documents announcing the availability of funding from Federal agencies. Members of the DHS-HHS Grant Programs Steering Committee reviewed their respective grants and other Federal funding programs. HHS, DHS, USDA, and DOT developed a program review chart, detailing transportation and border-related pandemic planning funding activities, and disseminated the chart to all identified programs and entities. This will assist in greater leveraging of funds and less duplication, allowing awardees from one funding program to better coordinate with awardees of another funding program in the same or neighboring jurisdiction.
5.1.2.2. Complete
DOT, in coordination with DHS, HHS, and transportation stakeholders, shall convene a series of forums with governors and mayors to discuss transportation and border challenges that may occur in a pandemic, share approaches, and develop a planning strategy to ensure a coordinated national response, within 12 months. Measure of performance: strategy for coordinated transportation and border planning is developed and forums initiated.
We are working with the National Governor’s Association (NGA) to coordinate outreach efforts to State and local stakeholders. The NGA is holding regional workshops and exercises to discuss State and local level pandemic planning and to distribute best practice guidance. In conjunction with our Federal partners, DOT continues to work with the NGA to coordinate an outreach strategy to State and local officials, to serve as the vehicle for distributing pandemic best practice information and to address immediate concerns of stakeholders.
5.1.3.2 In Progress
DHS, in coordination with DOT, HHS, DOC, Treasury, and USDA, shall work with the private sector to identify strategies to minimize the economic consequences and potential shortages of essential goods (e.g., food, fuel, medical supplies) and services during a pandemic, within 12 months. Measure of performance: the private sector has strategies that can be incorporated into contingency plans to mitigate consequences of potential shortages of essential goods and services.
Over the past year, the Federal Government has produced several tools for businesses of all types and sizes to assist them in planning for a pandemic. Several checklists have been produced that provide specific recommendations for pandemic planning. These checklists include information for businesses in general (Business Pandemic Influenza Planning Checklist), as well as Planning for U.S. Businesses with Overseas Operations, the Health Insurer Pandemic Influenza Planning Checklist, and the Travel Industry Pandemic Influenza Planning Checklist. These checklists have been used by State governments, local governments, and thousands of businesses and employers in this country and worldwide to improve their pandemic planning efforts.
5.1.4.1. Complete
HHS, in coordination with DHS, DOT, and DOL, shall establish workforce protection guidelines and develop targeted educational materials addressing the risk of contracting pandemic influenza for transportation and border workers, within 6 months. Measure of performance: guidelines and materials developed that meet the diverse needs of border and transportation workers (e.g., customs officers or agents, air traffic controllers, train conductors, dock workers, flight attendants, transit workers, ship crews, and interstate truckers).
We have prepared a Travel Industry Pandemic Influenza Planning Checklist (http://www.pandemicflu.gov/plan/workplaceplanning/travelchecklist.html).
We have also developed workforce protection guidelines for:
5.1.4.2. Complete
DHS, in coordination with DOT, DOL, Office of Personnel Management (OPM), and DOS, shall disseminate workforce protection information to stakeholders, conduct outreach with stakeholders, and implement a comprehensive program for all Federal transportation and border staff within 12 months. Measure of performance: 100 percent of workforce has or has access to information on pandemic influenza risk and appropriate protective measures.
We have developed guidance on workforce protection based on current policies and authoritative documentation. As new authoritative information becomes available, guidance will be updated and disseminated. Topics include use of masks and antiviral medications, universal precautions for transportation and border personnel in preventing the spread of pandemic influenza, and specific guidance for low, medium, and high-risk exposure workplaces. Agencies have developed interactive web-based training that provides guidance and background on protective measures employees can take to minimize risks.
5.1.4.3. In Progress
HHS, in coordination with DHS, DOT, DOD, Environmental Protection Agency (EPA), and transportation and border stakeholders, shall develop and disseminate decontamination guidelines and timeframes for transportation and border assets and facilities (e.g., airframes, emergency medical services transport vehicles, trains, trucks, stations, port of entry detention facilities) specific to pandemic influenza, within 12 months. Measure of performance: decontamination guidelines developed and disseminated through existing DOT and DHS channels.
Occupational safety guidelines under development include interim guidance for:
- Airline Cleaning Crew for an Arriving Aircraft with a Suspected Case of Pandemic Influenza,
- Cleaning an Emergency Medical Transport Vehicle after Transporting a Suspected Case of Pandemic Influenza,
- Cleaning Crew for a Train with a Suspected Case of Pandemic Influenza,
- Cleaning Crew for a Truck with a Suspected Case of Pandemic Influenza,
- Custodial Personnel for a Train or Bus Station with a Suspected Case of Pandemic Influenza,
- Custodial Personnel for an International Port of Entry Detention Facility with a Suspected Case of Pandemic Influenza,
- Cruise Line Cleaning Crew for an Arriving Cruise Ship with a Suspected Case of Pandemic Influenza, and
- Cleaning Crew for an Arriving Cargo Vessel with a Suspected Case of Pandemic Influenza
5.2.1.1. Complete
HHS and USDA, in coordination with DHS, DOT, DOS, DOD, DOI, and State, local, and international stakeholders, shall review existing transportation and border notification protocols to ensure timely information sharing in cases of quarantinable disease, within 6 months. Measure of performance: coordinated, clear interagency notification protocols disseminated and available for transportation and border stakeholders.
We have reviewed notification protocols to ensure that accurate information is available to border and transportation stakeholders in a timely manner. These protocols include communication chains for notification of Federal, State, and local stakeholders, both public and private, throughout the country. The protocols codify procedures already in use: 16 notifications of embargoes of live birds or unprocessed bird products have been issued since March 2006. Information about specific embargoes, import restrictions, or other regulatory actions is available to all stakeholders and the public at the following websites: www.aphis.usda.gov/vs/ncie/country.html#HPAI and www.cdc.gov/flu/avian/outbreaks/embargo.htm.
5.2.3.1. Complete
DHS, in coordination with HHS, DOT, DOS, and DOD, shall work closely with domestic and international air carriers and cruise lines to develop and implement protocols (in accordance with U.S. privacy law) to retrieve and rapidly share information on travelers who may be carrying or may have been exposed to a pandemic strain of influenza, within 6 months. Measure of performance: aviation and maritime protocols implemented and information on potentially infected travelers available to appropriate authorities.
We are using well-established aviation and maritime protocols to acquire and track public health data related to ill passengers. We have been working to make information on potentially infected travelers available to the appropriate authorities. We have developed a memorandum of understanding between Customs and Border Patrol and the CDC to facilitate requests for information on potentially infected international travelers in the event of a health emergency. An interagency group, coordinated by DHS, is actively engaged in developing a pandemic border health plan that will provide guidance to all levels of authorities to better manage border health risks. This plan will guide future training and exercises of protocols and procedures.
5.2.4.4. Complete
DOS and HHS, in coordination with DHS, DOT, and transportation and border stakeholders, shall assess and revise procedures to issue travel information and advisories related to pandemic influenza, within 12 months. Measure of performance: improved interagency coordination and timely dissemination of travel information to stakeholders and travelers.
We have formed an interagency working group to assess procedures regarding travel information and advisories in the event of an influenza pandemic. To streamline the process by which travel information is approved by agency representatives, the group has developed a protocol for seeking agency approval on short-fuse messages targeting Americans traveling or residing abroad. Several agencies have conducted tabletop exercises to develop and modify their communications and response protocols while addressing the public’s needs during a pandemic.
5.2.4.9 Complete
DHS, in coordination with DOS, HHS, Treasury, and the travel and trade industry, shall tailor existing automated screening programs and extended border programs to increase scrutiny of travelers and cargo based on potential risk factors (e.g., shipment from or traveling through areas with pandemic outbreaks) within 6 months. Measure of performance: enhanced risk-based screening protocols implemented.
We currently prohibit certain cargo from affected countries and target potentially infected cargo from affected countries through automated targeting systems. We are developing risk-based screening protocols to engage airlines and air carriers on the issue of en route screening. We will also engage foreign governments on the issue of screening international travelers at connection and transit points.
5.2.5.1. In Progress
HHS and DHS, in coordination with DOS, DOT, DOD, DOL, and international and domestic stakeholders, shall develop vessel, aircraft, and truck cargo protocols to support safe loading and unloading of cargo while preventing transmission of influenza to crew or shore-side personnel, within 12 months. Measure of performance: protocols disseminated to minimize influenza spread between vessel, aircraft, and truck operators/crews and shore-side personnel.
We are developing occupational safety protocols to support safe loading and unloading of cargo during an influenza pandemic, in order to minimize the spread of disease among vessel, aircraft, and truck operators/crews and shore-side personnel. Steps include:
- Adapting the Business Pandemic Influenza Planning Checklist to identify preparedness activities in the cargo transportation industry and assessing its usefulness at a large international (multimodal) vessel and rail cargo shipping firm;
- Contacting key agencies, industry associations, companies, and unions to identify current pandemic influenza preparedness planning activities and existing plans;
- Evaluating the relevance of existing occupational safety guidance and recommendations; and
- Drafting occupational safety protocols that make use of “universal precautions” that can be applied during an influenza pandemic.
5.2.5.2. Complete
USDA, in coordination with DHS, DOI, and HHS, shall review the process for withdrawing permits for importation of live avian species or products and identify ways to increase timeliness, improve detection of high-risk importers, and increase outreach to importers and their distributors, within 6 months. Measure of performance: revised process for withdrawing permits of high-risk importers.
We have revised the process for reviewing and canceling high-risk permits and communicated notification protocols to stakeholders. A new electronic permitting system has increased the efficiency of permit cancellations and withdrawals.
5.2.5.3. Complete
USDA, in coordination with DOI, DHS, shall enhance protocols at air, land, and sea ports of entry to identify and contain animals, animal products, and/or cargo that may harbor viruses with pandemic potential and review procedures to quickly impose restrictions, within 6 months. Measure of performance: risk-based protocols established and in use.
We currently have protocols in place to identify and contain animals, animal products, or cargo that could harbor influenza viruses with pandemic potential. The protocols have been reviewed to ensure that restrictions can be imposed quickly. Training seminars on the handling and quarantine of live birds have been completed by designated personnel and made available via the internet.
5.2.5.4. Complete
USDA, in coordination with DHS, shall review the protocols, procedures, and capacity at animal quarantine centers to meet the requirements outlined in Part 93 of Title 9 of the Code of Federal Regulations, within 4 months. Measure of performance: procedures in place to respond effectively and efficiently to the arrival of potentially infected avian species, including provisions for adequate quarantine surge capacity.
We have updated the protocols and procedures for handling birds, including smuggled birds that are encountered at ports of entry. Based on these protocols, we have determined that current surge capacity is adequate. Birds are safeguarded until the appropriate regulatory decision, which may involve quarantine, is made. Birds imported from a country affected by H5N1, however, are not allowed into the United States under any circumstance. These procedures have been incorporated into a bird handling seminar, which has been presented at ports of entry throughout the United States. Bird handling procedures are also referenced in a manual for CBP employees.
5.2.5.5. Complete
USDA, in coordination with DHS, DOJ, and DOI, shall enhance risk management and anti-smuggling activities to prevent the unlawful entry of prohibited animals, animal products, wildlife, and agricultural commodities that may harbor influenza viruses with pandemic potential, and expand efforts to investigate illegal commodities, block illegal importers, and increase scrutiny of shipments from known offenders, within 9 months. Measure of performance: plan developed to decrease smuggling and further distribution of prohibited agricultural commodities and products with influenza risk.
Representatives from DOJ, DOI, USDA, and DHS developed a plan to decrease the smuggling and distribution of prohibited agricultural commodities and products with influenza risk. The guidance provided in the plan will facilitate a comprehensive and coordinated approach to reducing risk at ports of entry as well as in commerce. Interagency collaboration and communication will continue, ensuring that future activities are well coordinated. Federal agencies are currently using the plan to enhance anti-smuggling activities related to avian influenza.
5.2.5.6. Complete
USDA, DHS, and DOI, in coordination with DOS, HHS, and DOC, shall conduct outreach and expand education campaigns for the public, agricultural stakeholders, wildlife trade community, and cargo and animal importers/exporters on import and export regulations and influenza disease risks, within 12 months. Measure of performance: 100 percent of key stakeholders are aware of current import and export regulations and penalties for non-compliance.
Informational materials on import and export regulations and influenza disease risks have been developed and distributed to 100 percent of the initial targeted stakeholders, including the public, agricultural stakeholders, the wildlife trade community, and cargo and animal importers/exporters. The materials currently are available through pandemicflu.gov, and the USDA, CBP, DOI/FWS, and CDC websites. Posters (in English, French, and Spanish) on illegal bird smuggling are being distributed to all air, land, and sea ports throughout the United States. An import/export booklet is posted on the internet and is being printed for hard copy distribution.
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6.1.1.3. Complete
DHS, in coordination with HHS, DOJ, DOT, and DOD, shall be prepared to provide emergency response element training (e.g., incident management, triage, security, and communications) and exercise assistance upon request of State, local and tribal communities and public health entities within 6 months. Measure of performance: percentage of requests for training and assistance fulfilled.
Our exercise and evaluation program provides direct support for State, local, and tribal exercises upon request. Exercises that address pandemic influenza response are eligible for funding support and vendor assistance. We have fulfilled 70 percent of submitted training requests thus far.
6.1.2.2. Complete
HHS, in coordination with DHS, DOD, and VA, shall develop a joint strategy defining the objectives, conditions, and mechanisms for deployment under which NDMS assets, U.S. Public Health Service (PHS) Commissioned Corps, Epidemic Intelligence Service officers, and DOD/VA health care personnel and public health officers would be deployed during a pandemic, within 9 months. Measure of performance: interagency strategy completed and tested for the deployment of Federal medical personnel during a pandemic.
We have developed a “playbook” that describes the public health and medical capabilities the Federal Government will bring to bear to support the National response to pandemic influenza. Its strategic principles have been tested in multiple exercises over the past year.
6.1.2.3. Complete
HHS, in coordination with DHS, DOT, DOD, and VA, shall work with State, local and tribal governments and leverage Emergency Management Assistance Compact agreements to develop protocols for distribution of critical medical materiel (e.g., ventilators) in times of medical emergency within 6 months. Measure of performance: critical medical material distribution protocols completed and tested.
We have developed a concise protocol that provides basic information on EMAC, refers practitioners to their State emergency management agency, provides links to other resources, and provides space for documenting State-specific information.
6.1.2.4 Complete
HHS, in coordination with DOD and VA, in collaboration with medical professional and specialty societies, within their domains of expertise, shall develop guidance for allocating scarce health and medical resources during a pandemic, within 6 months. Measure of performance: guidance developed and disseminated.
HHS developed a guidance document entitled “Providing Mass Casualty Care with Scarce Resources: A Community Planning Guide” that will help community leaders, as well as planners at the institutional, State, and Federal levels to plan for and respond to a mass casualty event. The document is not intended to reflect Federal policy but rather to provide State and local planners with options to consider when planning their responses. The guide is available at www.pandemicflu.gov and has been distributed at many national meetings.
6.1.2.5. Complete
HHS shall package and offer to the States and Territories the core operating components of an ESAR-VHP system within 6 months and encourage all States and tribal entities to implement the ESAR-VHP program by providing technical assistance and orientations at State and territory request to implement and operate Federal guideline (ESAR-VHP) compliant systems within 12 months. Measure of performance: guidance and technical assistance, as requested, provided to States to implement ESAR-VHP capability, compliant with Federal guidelines, in all States and U.S. territories.
HRSA defined the core requirements and timeframes that must be met by each State and Territory. These compliance requirements will be incorporated into the next version of the national ESAR-VHP guidelines due for release in the summer of 2007. Orientations have also been provided for all States and Territories.
6.1.2.6. Complete
HHS, in coordination with the USA Freedom Corps and Citizen Corps programs, shall continue to work with States and local communities to expand the Medical Reserve Corps program by 20 percent within 12 months. Measure of performance: increase number of Medical Reserve Corps units by 20 percent, from 350 to 420 units.
MRC has grown from 350 units to more than 654 units and 122,826 members.
6.1.2.7. Complete
HHS, in coordination with DHS, DOD, VA and the USA Freedom Corps and Citizen Corps programs, shall prepare guidance for local Medical Reserve Corps coordinators describing the role of the Medical Reserve Corps during a pandemic, within 3 months. Measure of performance: guidance materials developed and published on Medical Reserve Corps website (www.medicalreservecorps.gov).
MRC Pandemic guidance was posted in May 2006 (http://www.medicalreservecorps.gov/POUpdates/PandemicFluGuidance).
6.1.2.8 Complete
DHS, in coordination with the USA Freedom Corps, shall direct other Citizen Corps programs to prepare guidance detailing appropriate pandemic preparedness activities for each program, within 3 months. Measure of performance: guidance materials developed and published on Citizen Corps website and component program websites.
We have included specific links to preparedness checklists and current information on the Citizen Corps home website (www.citizencorps.gov) with instructions on how to access updated information. Affiliates have included specific pandemic influenza guidelines on their respective websites to ensure that current information is available. We are also working with all Citizen Corps components related to developing and disseminating specific guidance on pandemic influenza preparedness activities.
6.1.3.1. In Progress
HHS, in coordination with DHS, DOS, DOD, VA, and other Federal partners, shall develop, test, and implement a Federal Government public health emergency communications plan (describing the government’s strategy for responding to a pandemic, outlining U.S. international commitments and intentions, and reviewing containment measures that the government believes will be effective as well as those it regards as likely to be ineffective, excessively costly, or harmful) within 6 months. Measure of performance: containment strategy and emergency response materials completed and published on www.pandemicflu.gov; communications plan implemented.
The U.S Government Pandemic Influenza Public Health Communications Plan was finalized in November 2006. Core Plan elements include: communications goals, strategies, and tactics during a pandemic; the planning assumptions that will frame the U.S. Government communications response; the current agreed-upon Federal messages on pandemic influenza preparedness and response; and a comprehensive listing of target audiences, credible Federal expert spokespersons, and roles and responsibilities of the relevant Federal agencies.
6.1.3.2. Complete
HHS, in coordination with DHS, shall develop, test, update and implement (if necessary) a multilingual and multimedia public engagement and risk communications strategy within 6 months. Measure of performance: risk communication material completed and published on www.pandemicflu.gov and other venues; State summit meetings held.
Multiple public engagement and risk communication materials targeting key audiences have been produced and distributed via multiple channels. All checklists are available on pandemicflu.gov. Video versions of select Q&As as well as translations of some checklists and key materials into Spanish, Chinese, and Vietnamese are also available on pandemicflu.gov. Ten regional risk communications trainings have been held, and 50 state risk communications train-the-trainer sessions were completed by November 3, 2006.
6.1.3.3. Complete
HHS, in coordination with DHS, DOD, and the VA, and in collaboration with State, local, and tribal health agencies and the academic community, shall select and retain opinion leaders and medical experts to serve as credible spokespersons to coordinate and effectively communicate important and informative messages to the public, within 6 months. Measure of performance: national spokespersons engaged in communications campaign.
The U.S. Government has undertaken a number of efforts to engage medical, public health, tribal health, and the academic community local and regional spokespersons. Efforts include risk communications trainings to discuss crisis and emergency communication, and to support pandemic community and individual actions to reduce illness and death, restore or maintain calm, and engender confidence in the operational response. Through these trainings we created a cadre of 50 train-the-trainers to increase the numbers of credible spokespersons on the topic of pandemic influenza. Pandemic message maps are routinely shared with local partners to guide their communications planning and response.
6.1.4.1. Complete
State, local, and tribal public health and health care authorities, in collaboration with DHS, HHS, and the Department of Labor (DOL), should coordinate emergency communication protocols with print and broadcast media, private industry, academic, and nonprofit partners within 6 months. Measure of performance: coordinated messages from communities identified above.
In collaboration with other Federal departments, a risk communication strategy is being developed including risk communications sessions that train participants to serve as local spokespeople before, during, and after a pandemic. Third-party outreach efforts include: (1) development of planning checklists for State and local governments, the business community, schools, healthcare groups, and faith-based and community organizations; (2) ongoing sector briefings; and (3) the development of “push” communications mechanisms to the private sector.
6.1.4.2. Complete
DOT, in cooperation with HHS, DHS, and DOC, shall develop model protocols for 9-1-1 call centers and public safety answering points that address the provision of information to the public, facilitate caller screening, and assist with priority dispatch of limited emergency medical services, within 12 months. Measure of performance: model protocols developed and disseminated to 9-1-1 call centers and public safety answering points.
We have developed two documents: EMS Pandemic Influenza Guidelines for Statewide Adoption and Preparing for Pandemic Influenza: Recommendations for Protocol Development for 9-1-1 Personnel and Public Safety Answering Points (PSAPs). Both are intended to provide guidance to State and local agencies in developing their pandemic influenza plans and operational protocols and the role of EMS and 9-1-1 in preventing the spread of the disease. They provide general guidance, considerations, references, and ideas that can enhance the optimal delivery of emergency care and 9-1-1 services during an influenza pandemic.
6.1.6.1. In Progress
HHS, in coordination with DOD, VA, and State, local, and tribal partners, shall define the mix of antiviral medications to include in the Strategic National Stockpile (SNS) and State stockpiles and develop recommendations for how the different agents are to be used, within 6 months. Measure of performance: development of policy concerning the selection, relative proportions, and use of antiviral medications in SNS and State stockpiles.
Guidance is being developed by an interagency group and will be released soon.
6.1.6.2. In Progress
HHS, in coordination with DOD, VA, and State, local, and tribal partners, shall define critical medical material requirements for stockpiling by the SNS and States to respond to the diversity of needs presented by a pandemic, within 9 months. Measure of performance: requirements defined and guidance provided on stockpiling.
Guidance is being developed by an interagency group and will be released soon.
6.1.6.4. Complete
HHS, DOD, and VA and the States shall maintain antiviral and vaccine stockpiles in a manner consistent with the requirements of FDA’s Shelf Life Extension Program (SLEP) and explore the possibility of broadening SLEP to include equivalently maintained State stockpiles, within 6 months. Measure of performance: decision made on broadening SLEP to State stockpiles.
Current SLEP participants have stated their compliance with existing SLEP requirements as set forth in the Interagency Agreement and respective Memoranda of Agreement. DOD, HHS, and VA have determined that the inclusion of State stockpiles in the SLEP program is not feasible at this time.
6.1.7.1. In Progress
HHS, in coordination with DHS, DOJ, VA, and in collaboration with State, local, and tribal partners, shall determine the national medical countermeasure requirements to ensure the sustained functioning of medical, emergency response, and other front-line organizations, within 12 months. Measure of performance: more specific definition of sectors and personnel for priority access to medical countermeasures and quantities needed to protect those groups; guidance provided to State, local, and tribal governments and to infrastructure sectors for various scenarios of pandemic severity and medical countermeasure supply.
The draft guidance on pandemic vaccine and antiviral drugs includes recommendations targeting health care workers, emergency response personnel, and those who keep community services working.
6.1.9.1. Complete
HHS shall, to the extent feasible, work with antiviral drug manufacturers and large distributors to develop agreements supporting the Federal procurement of available stocks of antiviral drugs both during the pre-pandemic and pandemic periods, within 12 months. Measure of performance: new antiviral medications procured by SNS, within the constraints of industrial capacity; Federal contracts in place with antiviral drug manufacturers and distributors.
We have purchased a total of 37.4 million treatment courses of Tamiflu® and Relenza®, from Roche and GlaxoSmithKline respectively, for the Federal stockpile over the past 12 months. To date 29.8 million treatment courses have been received by the SNS, and the remaining 7.6 million treatment courses are due by the end of calendar year 2007. 12.6 million treatment courses of these influenza antiviral drugs will be ordered with expected delivery in 2008 to complete the Federal stockpile.
6.1.10.1. Complete
HHS, in coordination with the private sector, shall assess the ability of U.S.-based pharmaceutical manufacturing facilities to contribute surge capacity and to retrofit existing facilities for pandemic vaccine production. This assessment will be completed within 6 months and should inform efforts to expand vaccine capacity. Measure of performance: completed assessment.
Assessment of U.S. and global influenza vaccine manufacturing surge capacity is made quarterly through site visits and other communications to manufacturers, the International Federation of Pharmaceutical Manufacturers, and WHO. A summary table and graph of influenza vaccine manufacturing pandemic surge capacity and vaccine forecasts are provided after each analysis. A request for information was issued to ascertain manufacturer’s influenza vaccine capacity and needs for retrofitting existing facilities to produce pandemic influenza vaccines in an emergency. This resulted in the issuance of a RFP solicitation in June 2006 for retrofitting of existing facilities for pandemic influenza vaccine manufacturing. Two contracts for a total of $132 million were awarded in June 2007 to two vaccine manufacturers to renovate existing U.S.-based facilities for pandemic influenza vaccine production and to provide warm base manufacturing operations for at least 2 years with options for an additional 3 years. The national pandemic influenza vaccine manufacturing surge capacity is expected to double the current capacity and to provide at least 16 percent of the needed pandemic vaccine for the Nation.
6.1.10.2. In Progress
HHS, in coordination with DHS, DOD, VA, DOC, DOJ, and Treasury, shall assess within whether use of the Defense Production Act or other authorities would provide sustained advantages in procuring medical countermeasures, within 6 months. Measure of performance: analytical report completed on the advantages/disadvantages of invoking the Defense Production Act to facilitate medical countermeasure production and procurement.
An interdepartmental working group reviewed the first report on the use of the Defense Production Act (DPA) for pandemic preparedness and response in January 2007. A revised report expands upon each department’s DPA title programs, authorities and processes, newly emerging issues concerning acquisition of medical countermeasures, ancillary countermeasures, and services.
6.1.11.1. Complete
HHS shall assess its existing authorities and develop a plan of action to address any regulatory or other legal issues related to the expansion of domestic vaccine production capacity within 12 months. Measure of performance: regulatory and legal issues identified in assessment.
We have conducted an assessment of regulatory and legal issues related to expansion of domestic vaccine production capacity. Liability concerns have been remedied by the passage of the PREP Act of 2005, which provided liability immunity to vaccine manufacturers, distributors, and administrators from damage claims following the issuance of a public health threat declaration by the HHS Secretary. Whether the U.S. Government should pay royalty fees for acquisition of pre-pandemic and pandemic influenza vaccine for stockpiling has been addressed by HHS through their “order and consent” clause of the Bayh-Dole Act and the exercise of the non-exclusive licensing rights on patented inventions supported by Federal funds. The issuances of draft and final guidance by the FDA on the manufacturing of pandemic influenza vaccines in March 2006 and May 2007, respectively, have resolved and clarified any outstanding regulatory issues on the licensure of pre-pandemic and pandemic influenza vaccines.
6.1.11.2. Complete
HHS shall develop a protocol and decision tools to implement liability protections and compensation, as authorized by the Public Readiness and Emergency Preparedness Act (Pub. L. 109-148), within 6 months. Measure of performance: publication of protocol and decision tools.
Pandemic influenza PREP Act protocol and decision tools have been developed and published on www.pandemicflu.gov.
6.1.12.1. Complete
HHS shall collaborate with health care providers, industry partners, and State, local, and tribal public health authorities to develop public information campaigns and other mechanisms to stimulate increased seasonal influenza vaccination, within 12 months. Measure of performance: domestic vaccine use increased relative to historical norms.
An integrated communications campaign was launched in the fall of 2006 to increase vaccination rates for seasonal influenza. This nearly six-month campaign included traditional and new media outreach, public services announcements, paid advertising, and market research. As a result, more than 102 million doses of seasonal influenza vaccine were distributed during the 2006/2007 influenza season -- nearly 20 million doses more than ever in U.S. history.
6.1.13.1. In Progress
HHS, in coordination with DHS, DOD, VA, and DOJ, and in collaboration with State, local, and tribal partners and the private sector, shall ensure that States, localities, and tribal entities have developed and exercised pandemic influenza countermeasure distribution plans, and can enact security protocols if necessary, according to pre-determined priorities (see below) within 12 months. Measures of performance: ability to activate, deploy, and begin distributing contents of medical stockpiles in localities as needed established and validated through exercises.
Guidance and resources have been provided to State, local, tribal, and territorial governments to facilitate development of countermeasure distribution plans that describe activation, deployment, distribution, and security of assets (including antiviral drugs and other medical supplies) stored in State stockpiles and the Strategic National Stockpile (SNS). Recipients of pandemic influenza supplemental funding—which include all 50 State governments, four large cities, and eight territories—are required to complete and exercise their countermeasure distribution plans within the budget year.
6.1.13.2. In Progress
HHS, in coordination with DOD, VA, States, and other public sector entities with antiviral drug stockpiles, shall coordinate use of assets maintained by different organizations, within 12 months. Measure of performance: plans developed for coordinated use of antiviral stockpiles.
Planning continues to determine the optimal way to address the use of antiviral stockpiles and other assets.
6.1.13.4. In Progress
HHS, in coordination with DOD, VA, and in collaboration with State, local, and tribal governments and private sector partners, shall assist in the development of distribution plans for medical countermeasure stockpiles to ensure that delivery and distribution algorithms have been planned for each locality for antiviral distribution. Goal is to be able to distribute antiviral medications to infected patients within 48 hours of the onset of symptoms within 12 months. Measure of performance: distribution plans developed.
Guidance and resources have been provided to state, local, tribal, and territorial governments to facilitate completion of distribution plans for medical countermeasure stockpiles. Recipients of pandemic influenza supplemental funding are required to complete and exercise these plans within the budget year.
6.1.13.6. Complete
DOT, in coordination with HHS, DHS, State, local, and tribal officials and other EMS stakeholders, shall develop suggested EMS pandemic influenza guidelines for statewide adoption that address: clinical standards, education, treatment protocols, decontamination procedures, medical direction, scope of practice, legal parameters, and other issues, within 12 months. Measure of performance: EMS pandemic influenza guidelines completed.
We have developed two documents: EMS Pandemic Influenza Guidelines for Statewide Adoption and Preparing for Pandemic Influenza: Recommendations for Protocol Development for 9-1-1 Personnel and Public Safety Answering Points (Pass). Both are intended to provide guidance to State and local agencies in developing their pandemic influenza plans and operational protocols and the role of EMS and 9-1-1 in preventing the spread of the disease. They provide general guidance, considerations, references, and ideas that can enhance the optimal delivery of emergency care and 9-1-1 services during an influenza pandemic.
6.1.13.7. Complete
HHS, in coordination with DHS, DOT, DOD, and VA, shall work with State, local and tribal governments and private sector partners to develop and test plans to allocate and distribute critical medical materiel (e.g., ventilators with accessories, resuscitator bags, gloves, face masks, gowns) in a health emergency, within 6 months. Measure of performance: plans developed, tested, and incorporated into department plan, and disseminated to States and tribes for incorporation into their pandemic response plans.
DHS has developed and tested Pandemic Influenza Allocation and Distribution Plan: Guidance to Project Areas. The plan was tested in October 2006 and further testing of the response plan by HHS is scheduled from November 2006 to March 2007. It has been incorporated into the Department’s CDC Operations Plan and has been distributed to States for incorporation into their pandemic influenza response plans and for coordination with their respective local and tribal authorities.
6.1.14.1. In Progress
HHS, in coordination with DHS and Sector-Specific Agencies, DOS, DOD, DOJ, DOL, VA, Treasury, and State/local governments, shall develop objectives for the use of and strategy for allocating, vaccine and antiviral drug stockpiles during pre-pandemic and pandemic periods under varying conditions of countermeasure supply and pandemic severity within 3 months. Measure of performance: clearly articulated statement of objectives for use of medical countermeasures under varying conditions of supply and pandemic severity.
To plan how to best use a limited supply of pandemic influenza vaccine, experts from the Federal Government worked with States, businesses, and other organizations on how best to use vaccine to mitigate illness, to keep community services working, to protect national security, and to reduce loss to the economy. The resulting plan will soon be released for public comment.
A similar plan is being developed on the use of antiviral drugs during an actual pandemic, and will also be referred to the public for review. Experts from the Federal Government worked with State, local, and tribal public health officials to develop this guidance.
6.1.14.2. In Progress
HHS, in coordination with DHS and Sector-Specific Agencies, DOS, DOD, DOL, VA, Treasury, and State/local governments, shall identify lists of personnel and high-risk groups who should be considered for priority access to medical countermeasures, under various pandemic scenarios, according to strategy developed in compliance with 6.1.14.1, within 9 months. Measure of performance: provisional recommendations of groups who should receive priority access to vaccine and antiviral drugs established for various scenarios of pandemic severity and medical countermeasure supply.
To plan how to best use a limited supply of pandemic influenza vaccine, experts from the Federal Government worked with States, businesses, and other organizations on how best to use vaccine to mitigate illness, to keep community services working, to protect national security, and to reduce loss to the economy. The resulting plan will soon be released for public comment.
A similar plan is being developed on the use of antiviral drugs during an actual pandemic, and will also be referred to the public for review. Experts from the Federal Government worked with State, local, and tribal public health officials to develop this guidance.
6.1.14.3. In Progress
HHS, in coordination with DHS and Sector-Specific Agencies, DOS, DOD, DOL, and VA, shall establish a strategy for shifting priorities based on at-risk populations, supplies and efficacy of countermeasures against the circulating pandemic strain, and characteristics of the virus within 9 months. Measure of performance: clearly articulated process in place for evaluating and adjusting pre-pandemic recommendations of groups receiving priority access to medical countermeasures.
The draft guidance on pandemic vaccine and antiviral drugs includes a recommendation that it be reassessed at the time of a pandemic. This is important because past pandemics have been very different in their severity and in the groups that were most affected. Public health experts from the CDC will investigate outbreaks at the start of a pandemic to define how severe the pandemic is and who is at greatest risk. This information will be considered through the established policy process and vaccine and antiviral drug use guidance tailored to the specific pandemic situation.
6.1.15.1. Complete
HHS shall develop capability, protocols, and procedures to ensure that viral isolates obtained during investigation of human outbreaks of influenza with pandemic potential are sequenced and that sequences are published on GenBank within 1 week of confirmation of diagnosis in index case, within 6 months. Measure of performance: viral isolate sequences from outbreaks published on GenBank within 1 week of confirmation of diagnosis.
We support a high throughput genome sequencing center that is currently generating high quality influenza genome sequence data for avian and human influenza viruses in a state-of-the-art microbial genome sequencing facility at the Institute for Genomic Research (TIGR). As of May 21, 2007, 2,266 human and avian isolates have been completely sequenced, and genomic sequencing data has been released to GenBank in 45 days of completing the sequence for rapid and unrestricted access of the data by the scientific community. The facility is operating at a capacity to sequence 200 complete influenza genomes per month with capabilities in place to expand the number of viral genomes sequenced per month, in the event of a pandemic. In addition, the center can generate the complete viral genome sequence from a clinical sample in 2-3 days. HHS, in partnership with the Association of Public Health Laboratories (APHL), is prepared to publish sequence data on any human isolate of H5N1 detected in the United States within one week of obtaining a viral isolate.
6.1.15.2. Complete
HHS shall increase and accelerate genomic sequencing of known human and avian influenza viruses and shall rapidly make this sequence information publicly available, within 6 months. Measure of performance: increased throughput of genomes sequenced (versus FY 2005 baseline) and decreased time interval between completion of sequencing and publication on GenBank.
We support a high throughput genome sequencing center that is currently generating high quality influenza genome sequence data for avian and human influenza viruses in a state-of-the-art microbial genome sequencing facility at the Institute for Genomic Research (TIGR). As of May 21, 2007, 2,266 human and avian isolates have been completely sequenced, and genomic sequencing data has been released to GenBank in 45 days of completing the sequence for rapid and unrestricted access of the data by the scientific community. The facility is operating at a capacity to sequence 200 complete influenza genomes per month with capabilities in place to expand the number of viral genomes sequenced per month, in the event of a pandemic. In addition, the center can generate the complete viral genome sequence from a clinical sample in 2-3 days. Similarly, HHS, in partnership with the Association of Public Health Laboratories (APHL), can publish sequence data on any human isolate of H5N1 detected in the United States within one week of obtaining a viral isolate. Internationally, we work with WHO to encourage sharing of viruses from countries with avian influenza activity.
6.1.15.3. In Progress
HHS shall develop protocols and procedures to ensure timely reporting to Federal agencies and submission for publication of data from HHS-supported influenza vaccine, antiviral medication, and diagnostic evaluation studies, within 6 months. Measure of performance: study data shared with Federal agencies within 1 month of analysis and publication of clinical trial data following completion of studies.
We convened a working group that developed and approved protocols, including the mechanism for dissemination and notification of publication.
6.1.16.1. Complete
HHS shall continue to support the advanced development of cell-culture based influenza vaccine candidates. Measure of performance: research grants and/or contracts awarded to develop cell-culture based influenza vaccines against currently circul
