Pandemic Influenza Action Steps

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 0: New Domestic Animal Outbreak in At-Risk Country* WHO Phases 1 or 2 No new influenza virus subtypes have been detected in humans. However, a circulating animal influenza virus subtype poses a substantial risk of human disease
HHS Objectives: (1) Track avian outbreaks until control/resolution, (2) leverage international and domestic surveillance systems and (3) monitor for reoccurrence of avian disease and develop and exercise pandemic influenza response strategies and plans.
HHS Strategies: Assist in animal outbreak control; Prevent human infections with animal disease (early warning); coordinate intergovernmental completion of pandemic influenza contingency plans; ensure effective surveillance and reporting system; develop prevention strategies; support development and stockpiling of influenza antiviral drugs vaccine, and other countermeasures; assist in international surveillance and investigation; assist State, local and tribal partners on healthcare response planning; and maintain appropriate level of awareness among government and other essential partners.
*HHS activities in response to the domestic introduction of HPAI in birds and the HHS response to a single domestic case of poultry-to-human infection are described in the USDA Interagency HPAI H5N1 Playbook
	I. Immediate Actions

	A. Planning and Coordination
	Coordinate HHS support to USDA and DOS via the EMG	ASPR
	Participate in USDA and/or DOS-led interagency calls	ASPR/CDC/OGHA
	In coordination with DOS and USDA, prevent human Avian Influenza (AI) infection resulting from exposure to infected birds or other animals	CDC
	In coordination with USDA and DOL, provide recommendations and guidance to Federal and/or State agencies regarding worker safety and health, including articulating PPE requirements, use of antiviral prophylaxis, appropriate hygienic practices, and psychosocial support for persons with direct contact with sick, dead, and/or infected birds or other animals	CDC/ASPR/SAMHSA
	B. Animal Surveillance and Investigation
	5. Make subject matter expertise available to DOS and USDA, as requested	CDC
	Deploy an assessment team as requested to the affected country(s)	CDC/ASPR/OGHA
	In coordination with DOS and USDA, provide technical support to the WHO Influenza Network and Ministries of Health and Agriculture, as requested, to characterize new influenza viruses in animals that have pandemic potential	CDC/NIH/OGHA
	Assist USDA, as requested, in monitoring new influenza strain in poultry and swine	CDC/NIH
	o Request and receive animal isolates from USDA	CDC/NIH
	• Characterize the virus, determine susceptibility of the virus to antiviral drugs, determine if vaccine candidates protect against the virus, and determine if field diagnostic tests react with the isolates	CDC/NIH
	In coordination with DOS and USDA, make available to the affected country(s) available guidance on worker health and safety to prevent infection resulting from exposure to infected birds or other animals.	CDC

	D. Vaccine and Antiviral Drugs
	Field international requests for pre-pandemic vaccine and antiviral drugs in support of cullers	ASPR/OGHA
	Prepare for pre-pandemic vaccination of domestic cullers and others who would be involved in the slaughter of poultry and other potentially infected animalsupon arrival of HPAI in the US	ASPR
	o Deploy PHS CC to support pre-pandemic vaccination efforts for cullers, as needed.	ASPR/OSG
	E. External Communications
	Coordinate with DOS and USDA in communicating actions the government is taking regarding an avian outbreak and release information about the situation on pandemicflu.gov	ASPA
	In coordination with USDA, develop and distribute information to food industry and public, emphasizing proper food handling practices for poultry products and how cooked products will not present a risk	FDA/ASPA
	Routinely notify stakeholders regarding status of international animal outbreak(s)	ASPA/CDC/OGHA
	Participate in DOS and/or USDA JIC	ASPA
	Apprise stakeholders (National/State/Tribal/Local and other key sectors) to understand the nature of the risk of an avian outbreak in U.S. as well as the governmental response to managing the risk	ASPA/CDC/ASPR
	Utilize the Health Alert Network and other communication mechanisms, including conference calls with CSTE, NACCHO, ASTHO, NASPHV, to provide information to partners	CDC/ASPR
	II. Ongoing Actions/Issues

	A. Planning and Coordination
	Monitor completion, assess quality of, and provide guidance to fill gaps in pandemic related public health and medical preparedness and response plans at State, local, and Tribal levels	ASPR/CDC
	Develop and maintain plans for the ESF 8 response including the ESF-8 response structure, decisional authorities, trigger points and SOPs for health & medical interventions in all phases of pandemic, including regional and field leadership	ASPR
	o Pre-identify who will perform specific ESF-8 response activities and train accordingly	ASPR
	o Identify communications channels for the multi-region response and identify essential elements of information to be collected, analyzed and distributed in SITREPS during a pandemic	ASPR
	o Regularly review status of Federal medical materiel caches, including medical countermeasure stockpiles	ASPR/CDC/DoD/ VA
	o Exercise and rehearse with interagency partners	ASPR
	Routinely review risk status (i.e. health screening and vaccination status) of all federal and contractor employees who could potentially deploy in support of HHS pandemic emergency response and provide additional screening and vaccination as needed and available	ASPR/All HHS Operating and Staff Divisions
	o Pre-identify HHS staff who will require pre-pandemic vaccination and antiviral drug prophylaxis and those in Tiers 1-3 of the pandemic vaccine allocation strategy	ASPR/All HHS Operating and Staff Divisions
	o Routinely review and, as appropriate, update respirator fit-testing of HHS responders	ASPR/All HHS Operating and Staff Divisions
	B. Surveillance and Investigation (Global and domestic)
	Human Surveillance and Investigation
	Promote global surveillance efforts and detection of animal and human influenza infections with new and known subtypes	OGHA/CDC/DoD
	o Coordinate with the WHO Secretariat, HHS health attachés, and other countries’ experts to assist in international influenza outbreak and epidemiological investigations and characterize disease epidemiology	OGHA/CDC
	o Provide technical support to the WHO Influenza Network and Ministries of Health and Agriculture, as requested, to characterize new influenza viruses in animals that have pandemic potential	OGHA/CDC/NIH
	o Conduct major surveillance and response efforts in coordination with DoD-GEIS out of its Southeast Asian and Central/East African reference labs in Bangkok and Nairobi, the Armed Forced Research Institute of Medical Sciences (AFRIMS) and the US Army Medical Research Unit-Kenya (USAMRU-K), respectively	OGHA/CDC/DoD
	Develop and implement strategies to enhance domestic surveillance	CDC
	o Work with State, Local and Tribal partners to implement enhancements to the National Influenza Surveillance System	CDC
	o Establish process to rapidly produce and distribute reagents and assays used for identifying pandemic alert strains	CDC
	o Monitor preparedness and laboratory capacity for seasonal influenza and identify surge capacity	CDC
	o Establish processes and procedures for the rapid production, procurement, and distribution of reagents for laboratory testing and other ancillary supplies	CDC/FDA
	o Coordinate with AFHSC, AFMIC and NBIS regarding human surveillance data	CDC/DoD/DHS
	o Develop and exercise mechanisms to provide active and passive surveillance during a pandemic, both internationally and domestically	CDC
	Develop and refine strategies to quench or contain the spread of a novel influenza virus with pandemic potential.	CDC/ASPR
	o In coordination with DOS and DOD, develop plans for a rapid containment response to a pandemic influenza virus abroad	CDC/ASPR
	o In coordination with State and local public health authorities, develop plans for a rapid containment response to the initial introductions of a pandemic virus in the U.S.	CDC/ASPR
	In coordination with DHS, develop and refine strategies to delay entry of a pandemic influenza virus to the U.S.	CDC/ASPR
	o Develop screening plans for the air, land and maritime environments	CDC/ASPR
	o Identify specific ports of entry where screening will take place	CDC/ASPR
	o Identify and train screening staff	CDC/ASPR
	Animal Surveillance and Investigation
	Develop plans and strategies to enhance domestic surveillance and collaborate with international organizations to improve global surveillance to allow earlier detection of novel influenza viruses in animals	CDC/OGHA
	Develop plans and strategies to support the deployment of technical assistance as requested/required to affected country(s), in coordination with DOS and USDA	CDC/ASPR
	Work with State, Local and Tribal health departments to prevent importation of influenza infected birds and animals into the U.S.	CDC
	Assist USDA, as requested, in monitoring new influenza strain in poultry and swine	CDC/FDA
	o Characterize the virus, determine susceptibility of the virus to antivirals, determine if vaccine candidates protect against the virus, and determine if field diagnostic tests react with the isolates	CDC/NIH
	o Request and receive animal isolates from USDA	NIH/CDC/FDA
	C. Non-Pharmaceutical Interventions
	Develop and refine guidance on community mitigation strategies	CDC
	Create guidance on infection control measures for specialized settings including long-term care facilities, schools, daycare centers, hospitals, substance abuse and mental health facilities	CDC/ASPR
6, 13, 14	D. Vaccines and Antiviral Drugs
	Vaccine Production
	Resolve issues, whenever possible, related to indemnification and liability protection for affected entities, including pandemic vaccine manufacturers, pandemic vaccine distributors, and healthcare providers who administer pandemic vaccines	ASPR/OGC
	Develop a stockpile of pre-pandemic vaccine for influenza strains with pandemic potential and distribute to manufacturers	ASPR
	o Collect vaccine reference strain and reagents	CDC
	o Conduct pre-pandemic vaccine studies to determine protection against currently circulating strains	NIH/ASPR
	o Obtain investigational lots of candidate vaccine for novel influenza strains and conduct clinical testing, with testing data submitted to FDA for evaluation of safety and effectiveness	NIH/ASPR/FDA
	Support development and evaluation leading to U.S. licensure and manufacture of an influenza vaccine produced in cell culture	ASPR
	Expand U.S. based influenza vaccine manufacturing capacity, diversifying vaccine production methods and suppliers	ASPR
	Ensure capacity exists to produce adequate doses of seasonal influenza vaccine year- round	OPHS/CDC
	Provide regulatory guidance to vaccine manufacturers for the manufacture of pandemic vaccines	FDA
	Vaccine Purchase
	Work with manufacturers to expedite Federal pre-pandemic vaccine purchasing contracts.	ASPR/BARDA
	Work with manufacturers to develop mechanisms to expedite Federal pandemic vaccine purchasing contracts during a pandemic.	ASPR
	Vaccine Allocation
	Develop and refine existing guidance for targeting and allocating pre-pandemic and pandemic vaccine, based on epidemiology of the pandemic influenza virus	CDC/ASPR/NVPO
	o Evaluate “antigen sparing” strategies to maximize use of limited vaccine stocks	NIH/CDC/FDA/ASPR
	Provide State and Local partners with guidance on EUA procedures	FDA
	Vaccine Distribution
	Provide guidance on pre-pandemic and pandemic vaccine distribution and administration to State health departments and other stakeholders.	CDC/ASPR/IHS
	Provide regulatory guidance to vaccine manufacturers for the shipment of pandemic vaccines	FDA
	Prepare to distribute unlicensed vaccines (if needed) under FDA’s IND and EUA provisions in coordination with State and Local authorities	CDC/ASPR/FDA
	o Develop strict inventory control and record-keeping mechanisms for IND and EUA provisions to be implemented in coordination with State and local authorities	ASPR/CDC/FDA
	Vaccine Administration
	Develop strategies for rapid administration of vaccine(s) to groups receiving priority access at the Federal and State levels	ASPR/OPHS/CDC
	o Procure ancillary supplies to support vaccine administration	ASPR/CDC
	Vaccine Monitoring
	Develop minimum data elements needed at the national level to include State, date of administration, lot number, priority access group and 1st or 2nd dose	CDC
	Plan for ascertainment of state coverage rates via BFRSS.	CDC
	Antiviral Production and Purchase
	Prepare and review IND or EUA applications for approved antiviral drugs, if needed	FDA/ASPR
	Evaluate antiviral susceptibilities of influenza strains with pandemic potential	CDC/NIH
	Maintain a program to test and extend dating of stockpiled antiviral drugs, as needed, based on demonstration of continued potency	CDC/FDA
	Stockpile antiviral drugs for pandemic response	ASPR/CDC
	o Conduct federal direct purchase of 50 million treatment courses of licensed antiviral drugs for SNS stockpile	ASPR
	o Subsidize State purchases of 31 million treatment courses of a licensed antiviral for state stockpile	ASPR
	Antiviral, Diagnostics and Medical Device Allocation
	Assess status of available antiviral drugs, diagnostics and medical devices as well as related strategies for use	ASPR/CDC/FDA
	Develop strategies for rapid issue of antiviral drugs, diagnostics and medical devices to Federal and state groups receiving priority access	CDC/DoD/USDA/VA/ IHS/DOJ (BOP)/HRSA
	o Educate professional organizations and other stakeholders about priority-access group needs and the rationale for groups currently recommended	ASPA/NVPO/CDC
	Develop a decision making process to assess and prioritize requests for antiviral drugs, diagnostics and medical devices	ASPR/NVPO/CDC/ USDA
	Antiviral Drug Distribution
	Develop a distribution plan that clearly delineates Federal and State responsibilities for the distribution and dispensing of antiviral drugs.	ASPR/CDC
	Develop a plan to assist with security of production, storage and distribution of antiviral drugs prior to a pandemic	CDC/ASPR
	Develop strict inventory control and record-keeping mechanisms for IND and EUA provision to be implemented in coordination with State and local authorities.	ASPR/CDC/DoD/ FDA
	Antiviral Drug Administration
	Develop a plan to administer antiviral drugs within Federal healthcare systems	ASPR/IHS/NIH/DoD/VA
	Prepare to distribute antiviral drugs under FDA’s IND and EUA provisions (if needed) in coordination with State and local authorities	CDC/ASPR/IHS/NIH
	Provide State and local partners with guidance on IND and EUA procedures	ASPR/CDC/FDA
	Antiviral Monitoring
	Develop and review protocols for monitoring antiviral effectiveness, safety, and resistance during a pandemic	CDC/NIH/ FDA/ HRSA
	Develop a tracking system to report and monitor for adverse events related to antiviral therapies, diagnostics and medical devices	CDC/FDA/HRSA
	E. Healthcare Infrastructure
	Regularly review surge capacity of medical (including inpatient, outpatient, and long-term care facilities) and emergency response systems (e.g., EMS, beds, ventilators, diagnostics, etc.) to meet expected needs during a pandemic	ASPR
15	Prepare for Medicaid/Medicare-related waivers	CMS
	Develop consensus with State Health Departments, American Hospital Association (AHA), and Federal partners on definitions used to measure surge capacity and mechanisms for reporting to State and Federal authorities	AHRQ/ASPR
	Develop guidance on the allocation of scarce resources, including the use of alternative staffing plans to leverage scarce local public health and medical personnel.	AHRQ/ASPR
	Develop guidance on the establishment of alternate care sites	AHRQ/ASPR
	Develop sample model protocols for early detection and treatment of influenza and provide healthcare facilities with this protocol	CDC
	Develop and provide guidance for outbreak control measures in healthcare settings and other institutions such as long-term care facilities	CDC
	In coordination with DHS, estimate requirements and assess capacity of vendors and manufacturers to produce and distribute critical medical materiel in the event of a surge demand	ASPR/CDC
	Provide ongoing public health guidance for State, and local, tribal, and private-sector authorities and organizations on healthcare preparedness for an influenza pandemic	ASPR/ CDC
	F. Ports of Entry Operations
	At ports of entry, support prevention of importation of influenza-infected birds, animals, and unprocessed poultry products into the U.S.	CDC
	In coordination with DHS and DOT, develop plans for entry screening at air, land and sea ports.	CDC/ASPR
	G. External Communications
	Coordinate public health and medical communication preparedness activities across the USG and with State, local, tribal and international health partners	ASPA/ASPR
	o Develop key pandemic influenza messages and materials, conduct audience research and message testing, and share results with international governments, Federal agencies, State and local communications staff	ASPA
	o Identify and train lead spokespersons and alternates	ASPA
	o Determine clearance process for content and timing of messages, whether posted on web or given to media or local public health departments	ASPA
	o In coordination with DOS, create international information-exchange and communication strategies with the WHO Secretariat and other international partners, as appropriate	OGHA/ASPR
	Update Congress; State, local, and tribal health departments; local officials, other stakeholders, and the media on pandemic preparedness efforts	ASL/ASPA/CDC
	Develop and distribute guidance and risk communication tools for the general public	ASPR/All HHS Operating Divisions
	o In coordination with USDA, develop and distribute information to food industry and public, emphasizing proper food handling practices for poultry products and how cooked products will not present a risk	FDA/ASPA
	o Plan and convey public information on personal protection against pandemic influenza infection, for dissemination directly from local entities via State health departments	ASPA/CDC
	o Provide risk communication, updated guidance to the public, regarding presumed mechanisms of transmission and basic preventive measures	ASPA/CDC
	o Update and disseminate resource materials on psychosocial issues related to pandemic influenza	ASPA/CDC/ SAMHSA/NIH
	o Distribute educational materials for self-protective strategies through the media and other available outlets public.	ASPA/CDC

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 1: Suspected Human Outbreak Overseas Efficient (unconfirmed or suspected) human-to-human infection abroad
HHS Objectives: (1) Rapidly investigate and confirm or refute reports of human-to-human transmission and (2) initiate coordination mechanisms and logistical support that will be necessary if outbreak confirmed.
HHS Strategies: Enhance surveillance systems; initiate rapid deployment to support disease investigation; prepare for international and domestic deployments in support of international containment and delay operations.

	A. Planning and Coordination
	Initiate and sustain ongoing communication with ESF-8 partners regarding logistical and operational planning	ASPR
	Prepare for domestic deployments	ASPR/All
	o Roster personnel	ASPR/All
	o Conduct any necessary fit testing, health screening and/or vaccination (as applicable and available)	ASPR/All
	o Confirm logistical capability to support deployments, including transportation	ASPR/All
	Expand Interagency/Intergovernmental coordination	ASPR
3	B. International Surveillance and Containment
	In coordination with DoS and WHO, initiate dialogue with potentially affected nation(s) through diplomatic and health channels to ascertain situation, offer scientific and technical assistance, and encourage full and open sharing of information.	OGHA/ASPR/CDC DoS
	As requested, deploy Rapid Assessment Team to determine epidemiological situation and assess local capabilities and resources	ASPR/CDC
	In coordination with DoD, amplify laboratory-based and clinical surveillance in region	CDC/DoD
	Request DoD prepare to provide logistical support for deployment of stockpile materiel to region, including identification of necessary equipment, supplies and personnel.	ASPR/DoD
	Prepare to deploy reagents to support surge diagnostic requirements	CDC
	Implement plans and obtain necessary clearances to transport samples to U.S. or other key locations	OGHA/CDC
	Work with the travel industry, and in coordination with INS, USCG, quarantine stations, and CBP to ensure that airplane and cruise ship captains and crew are familiar with identifying and managing ill passengers and procedures for notification prior to arrival	CDC
	C. Domestic Surveillance Measures
11	Enhance domestic surveillance measures	CDC
	Provide technical guidance to States, local and tribal health departments, hospitals and other health care systems	CDC
	Verify that health surveillance systems are operational	CDC/HRSA/ASPR
	Update existing recommendations for identifying human cases of pandemic influenza and distribute via Health Alert Network (HAN), EPI-X and www.pandemicflu.gov	CDC/NIH
	Consult with international organizations to assess epidemiology of disease outbreaks and efficiency of person-to-person transmission, and to obtain parameter estimates to support real-time mathematical modeling	CDC/OGHA/ ASPR
	Ensure that laboratories in support of the LRN are operational and verify their analytical capability	CDC
6, 13, 14	D. Vaccines and Antiviral Drugs
	Vaccine Distribution
	Conduct final preparations for the distribution of pre-pandemic vaccine to Federal and state partners for administration to designated priority access groups	ASPR/CDC
	Antiviral Drug Distribution
	Conduct final preparations for the distribution of antiviral drugs to state-designated sites	CDC
	E. Healthcare Infrastructure
	Provide guidance to healthcare providers on clinical management, infection-control, and psychosocial support guidelines for hospitals, long-term care facilities (e.g., assisted living and group homes), outpatient settings, and EMS systems	CDC/SAMHSA
	Distribute sample model protocols for early detection and treatment of influenza and provide healthcare facilities with these protocols	CDC/NIH
	Update and disseminate national guidelines on use of antiviral drugs, vaccines, diagnostics and medical devices during the pandemic	ASPR/CDC/NIH/FDA/HRSA
	Prepare SNS to receive, store and issue medical supplies and equipment as required	CDC/ASPR
10	F. Ports of Entry Operations
	In coordination with DOS, issue Travel Health Warnings including recommendations against non-essential travel to affected countries	CDC/OGHA DoS
	If requested and as resources are available, support exit screening at airports/ports of entry (POEs) in affected country(s) in coordination with DOS	ASPR/CDC/OFRD
	In coordination with DHS and DOT, conduct final preparations for screening/quarantine measures at POEs	CDC/ASPR
	G. External Communications
	Issue Health Alert Network notice on the international situation	CDC/ASPA/ASPR/DoS
	Communicate change in USG Stage status to public in coordination with DHS and DOS	Sec HHS/ASPR/ASPA DoS
	Update Congress; Governors, Mayors, State, local, and tribal health departments; local officials, other stakeholders, and the media regularly	ASL/ASPR/ CDC/ASPA
	Coordinate communications activities with the WHO Secretariat, and State and local communications staff, including regional or local communications centers as appropriate	ASPA/ASPR/CDC/ OGHA
	Respond to rumors and inaccurate information to minimize concern, social disruption, and stigmatization	ASPA
	Update pandemicflu.gov website and provide rapid links to relevant information	ASPA

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 2: Confirmed Human Outbreak Overseas Evidence of 10-50 or more laboratory confirmed human cases of avian influenza in a single cluster, or the concurrent appearance of clusters of confirmed laboratory human cases in more than one country would indicate that sustained human-to-human transmission has begun
HHS Objectives: (1) Support the international response to contain the outbreak to the affected region(s) and limit potential for spread to the United States and (2) Enhance domestic public health and medical preparedness in anticipation of the arrival of cases in the U.S.
HHS Strategies: Activate ESF 8 to support interagency coordination, conduct international deployment of HHS staff, initiate actions to deploy and utilize medical countermeasures, and conduct final preparations for actions at ports of entry.

	A. Planning and Coordination
1	Declare a Public Health Emergency	Sec HHS
	Coordinate with ESF-8 Supporting Agencies, DHS, and the White House	ASPR
	Establish contact with key public health, healthcare, and community partners (i.e., State Health Department, State OEM, State Hospital Association, etc.)	ASPR
	Request OPHS/OSG activate all PHS CC and deploy as needed	ASPR
	Ensure COOP/COB planning for operations and headquarters is current	ASPR
2	Activate Emergency Management Group (EMG) and deploy Pandemic Influenza Senior Federal Officials and Incident Response Coordination Teams (IRCT)	ASPR
	Deploy ESF-8 representatives to staff regional JFOs and other multi-agency coordination elements	ASPR
	Determine Pandemic Severity Index based on international surveillance and case fatality ratio	CDC
3	B. International Containment
	In coordination with DoS, and in accordance with the HHS International Emergency Response Framework (IERF) support the International Containment Response	ASPR/CDC
	o As requested, deploy containment public health and medical assets to support containment efforts	ASPR/CDC
	o If DSNS commercial transportation is unavailable, request strategic transportation support from DOD to move critical medical and other resources to the containment area	ASPR/CDC/DOD
	o Request that DOD provide security for SNS materiel distributed outside the U.S. and to the containment area	ASPR/OGHA/CDC/ DOD/DOS
	Consult with international organizations to assess epidemiology of disease outbreaks and efficiency of person-to-person transmission, and to obtain parameter estimates to support real-time mathematical modeling	CDC/OGHA
6, 13, 14	C. Vaccines and Antiviral Drugs
	Vaccine Production
	Test for cross protection between pre-pandemic vaccine and the pandemic virus and make recommendations on use. Submit test results and recommendation(s) to FDA for evaluation in support of IND, EUA, or license, if necessary.	CDC/ASPR/NIH/FDA
	Evaluate dose-optimization strategies to maximize the use of pre-pandemic vaccine stocks	FDA/NIH/CDC/ ASPR
	Expedite the rapid development, licensure, and production of new influenza vaccines	ASPR/FDA/NIH/CDC
	o Facilitate use of reference strain to develop new vaccine.	ASPR/NIH/CDC
	o If stockpiled pre-pandemic vaccines are effective, surge production	ASPR/NIH/CDC
	o Direct manufacturer(s) to continue production of pre-pandemic vaccine until the virus reference strain for the circulating virus is available for manufacturing a well-matched vaccine (approximately 8 weeks)	ASPR/NIH/CDC
	o Direct manufacturer(s) to formulate previously manufactured pre-pandemic vaccine at best formulation and dispense into multi-dose vials	ASPR/NIH/CDC
	o Direct manufacturers to discontinue seasonal flu vaccine production in order to increase stock of pre-pandemic and pandemic vaccine	ASPR/OPHS
	o Obtain foreign U.S. licensed vaccine from manufacturer(s) for U.S.-based fill and finish if available	ASPR/FDA
	o Assess candidate pre-pandemic and pandemic vaccines for licensure	FDA/ASPR/NIH
	Vaccine Purchase
	Work with manufacturers to expedite Federal vaccine-purchasing	ASPR
	Vaccine Allocation
		ASPR/CDC/OPHS DHS
	Vaccine Distribution
	Initiate distribution of pre-pandemic vaccine by manufacturer to pre-designated sites	ASPR/CDC/DSNS
	o Evaluate and, if needed, provide security for the transportation of pre-pandemic vaccine.	ASPR/CDC/DSNS
	o Monitor security for transportation and distribution	ASPR/DoD
	Vaccine Monitoring
	Ascertain pre-pandemic vaccine coverage rates via BFRSS	CDC
	Estimate rates of reports of mild and severe adverse events following immunization (AEFIs) that may occur with mass influenza vaccination	CDC/FDA
	Surge capacity for responding to reported adverse events	CDC
	Initiate and review rapid clinical studies of pre-pandemic vaccine safety and immunogenicity and schedule as part of post-distribution safety/efficacy assessments	NIH/FDA/ASPR
	Provide any necessary and additional guidance to states for tracking vaccine doses administered, using either state vaccine registries or the CDC CRA system	CDC/NIH
	Antiviral Production
	Determine susceptibility of the novel influenza strain to antiviral drugs	CDC/NIH
	Assess candidate antiviral drugs, diagnostics and medical devices use via EUA or IND.	FDA/ASPR
	Expedite rapid development, approval, and production of new antiviral drugs, diagnostics and medical devices	FDA/ASPR/NIH
	Initiate surveillance efforts to identify counterfeit antiviral drugs and other medical products for preventing, treating and containing pandemic influenza	FDA
	Antiviral Purchase
	Work with manufacturer(s) to expedite purchasing of antiviral drugs, diagnostics and medical devices by both the public and private sectors	ASPR
	Provide regulatory guidance to manufacturer(s) for the manufacture, shipment and storage of pandemic antiviral drugs, diagnostics and medical devices	FDA
	Antiviral Distribution
	If directed, deploy antiviral drugs identified for domestic containment from the SNS to support Risk-Based Border Screening operations at air ports of entry into the U.S.	ASPR/CDC/DSNS
	If directed, begin pro rata antiviral distribution to States	ASPR/CDC/DSNS
	o Evaluate and, if needed, provide security in transporting/distributing antiviral drugs, diagnostics and medical devices	CDC
	o Request security support from ESF 13, as necessary	ASPR
12	IND/EUA Application and Process
	Initiate preparation and review of IND or EUA applications for vaccines, antiviral drugs, diagnostics and medical devices	ASPR/CDC/NIH
	D. Domestic Surveillance and Laboratory Measures
11	Enhance domestic surveillance measures	CDC
	Prepare and distribute reagents	CDC
	Ensure that in-vitro diagnostics have requisite approvals and labeling	FDA/CDC
	Develop, produce, and disseminate RT-PCR and immunofluorescence assays (IFA) reagents, as needed.	CDC
	Distribute reagents to Laboratory Response Network (LRN) laboratories, State public health laboratories and the WHO Global Influenza Surveillance Network	CDC
	Update the RT-PCR protocol for the identification of novel influenza subtypes	CDC
	Issue updated case definitions and guidance for specimen management, laboratory testing, and enhanced surveillance, in coordination with the WHO Secretariat	CDC
	Update existing recommendations for identifying human cases of pandemic influenza and distribute via Health Alert Network (HAN), EPI-X and www.pandemicflu.gov	CDC/NIH/

	E. Healthcare Infrastructure
	Monitor State vaccine and antiviral distribution activities	ASPR/CDC
	Provide updated guidance to healthcare providers on clinical management and infection-control guidelines for hospitals, long-term care facilities, outpatient settings, substance abuse and mental health facilities, and EMS systems	CDC/ASPR/SAMHSA
	Distribute sample model protocols for early detection and treatment of pandemic influenza and provide healthcare facilities with these protocols	CDC/NIH/HRSA
	Evaluation of international clinical outcomes and refinement of optimal treatment strategies	CDC

9, 10	F. Ports of Entry Operations
	Take steps, as necessary, to finalize proposed quarantine regulations found in 42 CFR (parts 70,71) and modify the list of diseases of public health significance (part 34) affecting admissibility of certain aliens to include pandemic influenza.	CDC/ASPR
	In coordination with DOS and DHS, consider implementation of support strategy for exit screening at airports in affected countries and major transit hubs	ASPR/CDC
	o Work with WHO, DOS, and DHS to obtain international support and clearance for implementation	OGHA/CDC/ASPR
	o Advocate for WHO coordination of exit screening support to affected countries	CDC/OGHA
	o As requested, deploy personnel to conduct exit screening for symptoms and signs of influenza illness	ASPR/CDC
	In coordination with DHS and DOT, consider implementation of active aviation entry screening protocols	ASPR/CDC
	o Deploy personnel to support aviation entry screening, including PHS CC and NDMS	ASPR/CDC
	Coordinate with local communities on housing for quarantined passengers	ASPR/CDC
4, 5	o Consider the use of FMS as a temporary quarantine facility	ASPR/CDC
	In coordination with DOS, issue Travel Health Warnings including recommendations against non-essential travel to affected countries; and arrange with travel industry partners to play videos or public announcements about pandemic influenza on airplanes and cruise ships	OGHA/CDC
	G. External Communications
	Issue Health Alert Network notice on the international situation	CDC
	Communicate any changes in USG Response Stage status in coordination with DHS and DOS, and through the International Health Regulations Program to WHO	Sec HHS//ASPR/ASPA
	Update Congress; Governors, Mayors, State, local, and tribal health departments; local officials, other stakeholders, and the media regularly	ASPR/All
	Distribute practical information, such as: travel advisories; infection-control measures; availability and appropriate use of antiviral medications, vaccines, diagnostics and medical devices; and specific public health actions that may be advised	CDC/ASPA/OD/FDA//HRSA
	Provide ongoing public health and medical guidance through HAN, EPI-X and www.pandemicflu.gov	ASPA/CDC
	Communicate change in USG Stage status to public in coordination with DHS and DOS	Sec HHS/ASPR/ASPA

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 3: Widespread Human Outbreaks in Multiple Locations Overseas
HHS Objectives: (1) Delay the emergence of pandemic influenza in the U.S. and North American populations through risk based border interventions, (2) Leverage domestic surveillance systems to ensure the earliest warning possible of the first case(s) in the United States and (3) Continue to prepare the United States for the potential onset of the pandemic.
HHS Strategies: Conduct entry screening at select airports, deploy medical countermeasures to States and Territories

	A. Planning and Coordination
	Continue to ensure that COOP/COB planning for operations and headquarters is current	ASPR
2	Maintain activation of the Emergency Management Group (EMG) and deployment of Incident Response Coordination Teams (IRCTs)	ASPR
	Continue deployment of ESF-8 representatives for staffing of the regional JFOs and other multi-agency coordination elements (e.g., NRCC, NOC etc)	ASPR
	B. Surveillance and Investigation (Global and domestic)
	Continue efforts with international partners in carrying out epidemiological assessments, containment and other surveillance measures	CDC/OGHA/ASPR
	Accelerate domestic surveillance activities, including case identification, monitoring and reporting	CDC/ASPR

6, 13, 14	C. Vaccines and Antiviral Drugs
	Vaccine Production
	Change from seasonal to pre-pandemic (or pandemic) vaccine production, once reference strain is available	ASPR/OPHS
	Vaccine Purchase
	Finalize funding stream and contracts to complete pre-pandemic and pandemic vaccine purchase goals	ASRT/ASPR
	Vaccine Allocation, Distribution and Administration
	Continue to enact Federal allocation, distribution and administration plans	ASPR
	Advise States to prepare for activation of allocation, distribution and administration plans	ASPR/CDC
	Antiviral Production
	Continue surveillance efforts to identify counterfeit antiviral drugs and other medical products promoted for preventing, treating and containing pandemic influenza	FDA
	Continue to assess candidate antiviral drugs, diagnostics and medical devices for approval	FDA/ASPR
	Accelerate rapid development, approval, and production of new antiviral drugs, diagnostics and medical devices	FDA/ASPR/NIH
	Antiviral Purchase
	Continue work with manufacturer(s) to expedite purchasing of antiviral drugs, diagnostics and medical devices by the public and private sectors	ASPR
	Continue to provide regulatory guidance to manufacturer(s) for the manufacture, shipment and storage of pandemic antiviral drugs, diagnostics and medical devices	FDA
	Antiviral Distribution
	Accelerate antiviral distribution	CDC
	o Monitor security requirements	CDC
	o Request ESF 13 assistance if security support required	ASPR
	Vaccine and Antiviral Monitoring
	Continue to monitor for adverse events related to pandemic influenza medical products (i.e., antiviral drugs, vaccines, and medical devices)	FDA
12	IND/EUA Application and Process
	Accelerate review of INDs and EUAs for pandemic influenza medical products	FDA

	D. Healthcare Infrastructure
	Recommend States activate surge capacity plans	ASPR
	Identify best practices in pandemic treatment, as demonstrated in affected countries	CDC
	Distribute to healthcare providers the current case definition, clinical management guidelines, and CDC recommendations for enhanced surveillance for the detection of the first cases of the pandemic in their region	CDC
	E. Ports of Entry Operations
	If not yet begun, initiate aviation entry screening operations in coordination with DHS and DOT.	CDC/ASPR
	In coordination with HHS and DOS, monitor and evaluate implementation of the aviation entry screening of North American partners (Continental Approach)	ASPR/CDC
	o If implementation of the Continental Approach fails, consider entry screening at US land border ports of entry in coordination with DHS	ASPR/CDC
	Consider activation of entry screening activities at Maritime ports of entry	ASPR/CDC
	o Deploy personnel to support aviation entry screening, including PHS CC and NDMS	ASPR/CDC
	In coordination with FEMA, coordinate with local communities on housing for quarantined passengers	ASPR/CDC
4, 5	o Consider the use of FMS as a temporary quarantine facility	ASPR/CDC
	F. External Communications
	Provide preparedness guidance to private citizens	ASPA/ASPR/CDC
	Communicate change in USG Stage status to public in coordination with DHS and DOS	Sec HHS/ASPR/ASPA

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 4: First Human Case(s) in North America
HHS Objectives: (1) Delay the emergence of pandemic influenza in the U.S. (if no cases in the U.S.), (2) Coordinate with affected localities to attempt to contain the first outbreaks within the U.S. (if cases in the U.S.) and (3) Continue efforts to prepare the United States for the potential onset of the pandemic
HHS Strategies: Use the HHS antiviral drug strategic reserve to support disease control activities in the first affected communities, maintain screening efforts at ports of entry and complete deployments of medical countermeasures

	A. Planning and Coordination
	Confirm and report pandemic disease in the U.S.	CDC/ASPR
	Continue to track deployment of ESF-8 response assets	ASPR
	Continue to track/map international and domestic cases	ASPR
	Phase out USG pandemic surveillance presence in the affected area abroad	OGHA/CDC
	Recall international antiviral support and outbreak investigation teams	ASPR/CDC

	B. Surveillance and Containment Activities
	Investigate apparent initial U.S. cases	CDC
	Support disease containment and control activities in the first affected communities	CDC
	o Deploy personnel to support affected States	ASPR/CDC
	o Deploy antiviral drugs from the Strategic Reserve to support disease control	ASPR/CDC
	Ensure ongoing reporting of virological and surveillance data	CDC
	Implement studies of spread in communities and families; identify risk factors for infection and adverse health outcomes	CDC
16	Discourage domestic movement restrictions	ASPR/CDC
17	11. Recommend community mitigation guidance strategies in affected communities	CDC/ASPR
	o Provide technical guidance to State, local, and tribal health departments regarding community mitigation measures	CDC
6, 13, 14	C. Vaccines and Antiviral Drugs
	Vaccine Production & Purchase
	During efforts at containment, continue vaccine acquisition using pandemic vaccine	ASPR
	Provide forecasts of pandemic vaccine availability from manufacturers	ASPR/CDC/FDA
	Review and approve EUAs for new vaccine	FDA/ASPR
	Vaccine Allocation & Distribution
	Maintain vaccination allocation strategy	ASPR
	Accelerate distribution of vaccine(s)	CDC
	Ensure that security is provided for transport of vaccine from the manufacturer to state-designated administration sites	CDC
	o Request ESF 13 support as necessary	ASPR
	Plan for vaccination procurement and distribution to clinics and other facilities. Account for the need for second doses, thus reducing the number of available first doses	CDC/NVPO
	Vaccine Administration/Monitoring
	Monitor vaccine use	CDC/FDA
	Assist in providing resources and personnel for vaccine administration	ASPR
	Provide any necessary and additional guidance to states for tracking vaccine doses administered, using either state vaccine registries or the CDC CRA system	CDC/NIH
	Monitor that vaccine distribution follows existing plans for priority access groups	OPHS/CDC
	Monitor adverse events associated with vaccine use	CDC/FDA
	Evaluate vaccine effectiveness; re-evaluate vaccine dose and schedule	FDA/NIH
	Implement protocols and databases for monitoring vaccine effectiveness and safety, and for tracking vaccine usage, including second dose uptake	NIH/CDC/FDA
	Implement existing vaccine-monitoring systems to allow population-based surveillance for adverse events	CDC/FDA
	Antiviral Drugs-Production & Purchase
	Continue purchase of antiviral drugs, diagnostics and medical devices	CDC/ASPR
	Continue surveillance efforts to identify counterfeit antiviral drugs and other medical products promoted for preventing, treating and containing pandemic influenza	FDA
	Antiviral Drugs-Allocation
	Use antiviral drugs, diagnostics and medical devices to support strategy for disease containment	CDC/ASPR
	Continue to allocate antiviral drugs	CDC
	Revise allocation strategy as needed	CDC
12	Review and approve EUAs and INDs for new antiviral drugs, diagnostics and medical devices if available and supported by data	FDA/ASPR
	Antiviral Drugs- Distribution
	Deploy antiviral drugs from the Strategic Reserve to support domestic containment activities	ASPR/CDC
	o Monitor security for transportation and distribution	CDC
	Antiviral Drugs-Administration/Monitoring
	Monitor use of antiviral drugs, diagnostics and medical devices	CDC
	Review submitted protocols for monitoring effectiveness and safety of antiviral drugs, diagnostics and medical devices during a pandemic	CDC/NIH/FDA
	Support data-collection efforts on the distribution of State or Federal supplies of antiviral drugs, the occurrence of adverse events following administration of antiviral drugs, the effectiveness of treatment and prophylaxis, and drug resistance	FDA/CDC/NIH
	Conduct studies and review data on antiviral drug resistance	CDC/NIH/FDA

	D. Healthcare Infrastructure
	Advise all States, Tribes and localities to activate pandemic-influenza response plans to coordinate healthcare delivery and community response	ASPR
	Evaluate international clinical outcomes to optimize treatment strategies	CDC
	Complete any remaining deployments of medical countermeasures including antiviral drugs and medical materiel	ASPR/CDC
8	Trigger the healthcare community to implement protocols related to surge capacity and the allocation of scarce resources.	ASPR
	Continue to distribute to healthcare providers the current case definition, clinical management guidelines, and CDC recommendations for enhanced surveillance for the detection of the first cases of the pandemic in their region	CDC/ASPR
	Ensure that EIP and NVSN hospitalization surveillance is active	CDC/NIH
15	Consider waiving healthcare requirements	CMS
9, 10	E. Ports of Entry Operations
	Continue to support aviation and maritime entry screening operations	CDC/ASPR
	If warranted or requested by WHO, initiate exit screening at all U.S. international airports in coordination with DHS and DOT	ASPR/CDC
	If no cases in US, but cases in Mexico and/or Canada, consider entry screening an land borders in coordination with DHS	ASPR/CDC
	F. External Communications
	Update Congressional staff members and committees as needed	ASL
	Continue issuance of formal announcements to public	Sec HHS/DHS/ASPA
	Deliver messages on protective health, containment measures, and psycho-social support to affected communities, business sectors, and providers	ASPA/CDC/OSG/FDA/ /SAMHSA/CMS/ HRSA
	Advise public on how to contact local resources	ASPA
	Provide needed information/education related to pandemic influenza vaccine, anti-viral, diagnostics and devices.	ASPA/FDA/CDC/ HRSA/CMS

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 5: Spread throughout United States
U.S. Strategy: Domestic disease control

	A. Planning and Coordination
	1. Accelerate coordination of response activities through the SOC and support ongoing communication with ESF-8 Partners and others (e.g., White House)	ASPR
	2. Report casualty and morbidity counts, with official release to public via ASPR	CDC/ASPR

	B. Domestic Surveillance Measures
	1. Initiate active reporting and enhanced surveillance for mortality and severe morbidity in affected areas	CDC
	2. Test patient specimens to identify pandemic outbreaks in communities and contribute to management decisions	CDC/NIH
	3. Once the virus has been identified throughout a State, decrease the level of diagnostic testing baseline	CDC
	4. Advise states on when confirmatory diagnostic testing (i.e., subtyping) of clinical specimens is required. The level of confirmatory diagnostic testing will decrease as the virus becomes widespread.	CDC
	5. Advise states on the percentage of isolates per week or month that should be sent to CDC as part of efforts to monitor changes in the antigenicity and antiviral susceptibility of the pandemic virus	CDC
	6. Throughout the pandemic, provide updated instructions on the collection of clinical and epidemiological data that should accompany isolates	CDC

17	C. Domestic Control Measures
	1. Assess impacts of community mitigation strategies	CDC
	2. Provide guidance on community mitigation measures	CDC


13, 14	D. Vaccine
	Vaccine Allocation and Distribution
	1. Maintain vaccine(s) allocation and distribution strategies according to current policies	NVPO/ASPR
	2. Maintain security strategies	CDC
	3. Procure/restock vaccine in preparation for subsequent waves	CDC/ASPR
	Vaccine Administration/Monitoring
	4. Determine effectiveness, safety, and impact of the vaccine(s)	FDA/NIH/ASPR
	5. Provide ongoing and timely monitoring of vaccine(s) coverage	CDC
	6. Provide ongoing and timely monitoring of vaccine(s) safety	FDA
	7. Determine potential vaccine(s) formulation or administration changes to improve efficacy or supply	FDA/NIH/NVPO/CDC/ASPR

6	E. Antiviral Production and Allocation
	1. Continue to acquire antiviral drugs, diagnostics, and medical devices	CDC
	2. Maintain antiviral allocation and distribution strategies according to current policies	CDC
	3. Procure/restock antiviral drugs, diagnostics, and medical devices in preparation for subsequent waves	ASPR/CDC
	4. Determine effectiveness, safety and impact of antiviral drugs, diagnostics, and medical devices	FDA/NIH/ASPR
	5. Continue surveillance efforts to identify counterfeit antiviral drugs and other medical products promoted for preventing, treating and containing pandemic influenza	FDA

4, 5, 7	F. Healthcare and Other Critical Infrastructure/Key Resources Protection
	1. Deploy available ESF-8 personnel to provide technical assistance and/or medical support to HHS and other Federal healthcare infrastructures	ASPR à ESF-8 Supporting Agencies
	2. If available, deploy available FMS and other ESF-8 assets to supplement community-based medical facilities in key locales, especially in medical management of patients with chronic conditions and other surge-related areas, as needed.	ASPR à ESF-8 Supporting Agencies

	3. Share “best practices” information with States regarding the use of non-traditional personnel (include first responders, medical students, pharmacists) to perform clinical functions.	ASPR
	4. Evaluate clinical outcomes and refine optimal treatment strategies	CDC/FDA/AHRQ
	5. Communicate lessons learned to healthcare providers and public health agencies on effectiveness of clinical treatments and public health measures	ASPA/CDC/OSHA

9, 10	G. Ports of Entry Operations
	1. Determine when operations at POEs can be lifted, if not done previously, in coordination with DHS and DOT	ASPR/CDC

	H. External Communications
	1. Refine and deliver accurate messages	ASPA/OSG/CDC
	2. Provide psychosocial support to responders and affected communities through institutionalization of psychosocial support services and development of workforce resiliency programs	SAMHSA/CDC
	3. Meet with Congressional staff members and committees as needed	ASL
	4. Determine the effectiveness of risk communication activities, adjusting as necessary to achieve public health communications objectives	ASPA
	5. Update HHS website and provide rapid links to relevant information	ASPA
	6. Address rumors, misperceptions, stigmatization, and unrealistic expectations about the capacity of public and private health providers	ASPR/ASPA
	7. Conduct "desk-side briefings" and editorial roundtables with news media decision-makers	ASPR/ASPA
	8. Maintain scheduled access to SMEs	ASPA/ASPR
	9. Communicate with leadership across jurisdictional tiers	ASPA/ASPR/ CDC
	10. Activate the CDC-INFO telephone line to provide relative information to the public	ASPA/CDC

Paper	Actions/Issues	Lead Agency/ Supporting Agencies
Stage 6: Recovery and Preparation for Subsequent Waves
U.S. Strategy: Recovery of critical infrastructure/key resources/social support systems and evaluation of lessons learned.

	A. Planning and Coordination
	• Continue coordination of response activities through the EMG and IRCTs	ASPR
	• Coordinate with the Interagency, including DHS and DOS, and the White House	ASPR
	• Revise response plans, as needed	ASPR
	• Redeploy and refit Federal ESF 8 response assets	HHS/ESF-8 Supporting Agencies
	• Maintain essential HHS functions and ensure continuity of operation through subsequent waves – should also be in stage 5	DHS/ESF-8 Supporting Agencies
	• Review lessons learned to develop strategies for subsequent waves	HHS/ESF-8 Supporting Agencies

	B. Domestic Surveillance Measures
	1. Once the virus has been identified throughout a State, decrease the level of diagnostic testing to baseline	CDC
	2. Provide continuously updated information to Federal government partners and States about the epidemiology of the virus	ASPR/CDC

	C. Domestic Control Measures
17	1. Assess impacts of community mitigation strategies	CDC
	2. Communicate lessons learned to healthcare providers and public health agencies on effectiveness of clinical treatments and public health measures	ASPA/CDC

	D. Vaccines and Antiviral Drugs
	1. Continue production of pandemic vaccine for preparation for subsequent waves	ASPR
	2. Assess impact of antiviral use strategies	ASPR/CDC
	3. Continue restocking of vaccines, antiviral drugs, diagnostics and medical devices in preparation for subsequent waves	ASPR/CDC
	4. Revisit priority access group recommendations, as deemed necessary	ASPR/NVPO/CDC

	E. Healthcare and Other Critical Infrastructure/Key Resources Protection
	1. Work with private sector, State, local and tribal entities to prioritize and begin restoring essential services and reviewing plans to maintain continuity of operations in subsequent waves with support of employees that are immunized or have developed immunity	ASPR
	2. Maintain continuous situational awareness of disease in communities, in order to forecast the reduction in illness and reduction in strain on critical infrastructure/key resources	ASPR

	F. Ports of Entry Operations
	• Return to normal operations, prepare for new waves of pandemic, and assess utility of screening measures, in coordination with DHS and DOT	ASPR/CDC

	G. External Communications
	1. Advise that additional waves of pandemic may occur and emphasize need to prepare accordingly	ASPA/CDC/ASPR

Pandemic Influenza Playbook

Comment on the Pandemic Influenza Playbook

Pandemic Influenza Action Steps

Stage 0: New Domestic Animal Outbreak in At-Risk Country*

Efficient (unconfirmed or suspected) human-to-human infection abroad

Stage 2: Confirmed Human Outbreak Overseas

Stage 3: Widespread Human Outbreaks in Multiple Locations Overseas