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Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
"This document is intended to provide to you, sponsors of pandemic influenza vaccines, guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines where the intended indication is for active immunization in persons at high risk of exposure to, or during a pandemic caused by, pandemic influenza viruses. We, FDA, also discuss pursuing licensure of an influenza vaccine for indication and usage during the prepandemic stage in Section III.D.5. -- Investigating Schedules for Administration for Use Prior to a Pandemic. The approaches in this guidance apply to both nonadjuvanted and adjuvanted hemagglutinin-based pandemic vaccines, including 'split virus,' subunit, and whole virus inactivated vaccines propagated in embryonated chicken eggs or cell-culture, and to recombinant hemagglutinin-based protein vaccines, and DNA vaccines that express hemagglutinin. We also address live attenuated influenza vaccines. This document does not address influenza vaccines that do not rely on immunity to a hemagglutinin component. This document does not address the nonclinical development of investigational vaccines. Successful nonclinical evaluation is an important step before proceeding with clinical development (Ref. 1). This document also does not address the chemistry, manufacturing, control, or inspection of the manufacturing facility needed for licensure. These aspects of the license application are addressed in the guidance document entitled, 'Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishment Description Information for a Vaccine or Related Product.' 1 Applicants may contact the Center for Biologics Evaluation and Research (CBER) for additional information about these aspects of vaccine development."
Center for Biologics Evaluation and Research (U.S.)
2007-05
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LLIS Lesson Learned: Crisis Communications: Releasing Public Information in a Timely Manner
Emergency managers should make certain that critical public information is approved and released in a timely manner. This can help ensure that the public receives vital information in time to make critical decisions.
United States. Department of Homeland Security; Lessons Learned Information Sharing (LLIS)
2007-04-27?
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Pandemic Influenza Clinical and Public Health Guidelines for the Military Health System
"The Military Health System (MHS) must be prepared to rapidly evaluate and effectively manage patients with suspected or confirmed pandemic influenza throughout the entire range of military operations and health care settings. In addition to providing health care, efforts must limit the spread of disease among service members, their families, local communities, and the workplace. These guidelines represent a recommended approach for the MHS with respect to patient evaluation and management, laboratory planning and diagnostics, occupational safety and health for health care and medical research personnel, community disease containment, and patient care and transport during military deployments."
United States. Department of Defense
2007-04-23
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National Strategy for Pandemic Influenza email announcement
Announcement of the launch of the National Strategy for Pandemic Influenza page on LLIS.gov.
Lessons Learned Information Sharing (LLIS)
2007-04-17?
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Community Corrections' Preparedness for Responding to Pandemic Flu and Other Crises: A Report of Responses to a Request for Information
Under a cooperative agreement with the Bureau of Justice Assistance, U.S. [United States] Department of Justice, the American Probation and Parole Association (APPA), will provide guidance to community corrections agencies in formulating strategic plans and protocols for responding to pandemic flu and other crises. One of the first steps toward this goal is to collect information about existing plans and protocols. This preliminary report summarizes the responses to a request for information that was sent by APPA to agencies across the Country.
American Probation and Parole Association
Bancroft, Patricia
2007-04-17
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Wisconsin Pandemic Influenza Operations Plan: All Priorities and Appendix A
This document published by the Wisconsin Department of Health and Family Services, Division of Public Health provides an operations plan for the various sectors of the Wisconsin infrastructure to deal with an influenza pandemic. Each sector has a set of priorities for which it must develop an operation plan. The state of Wisconsin sectors covered in this plan include: Health, Education, Critical Infrastructure, Economy, Trade and Business, State Workforce, Safety and Public Security, Agriculture and Food, Foreign diplomatic missions.
Wisconsin. Division of Public Health
2007-04-16
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Alabama's Pandemic Influenza: Operational Plan
"Alabama is well prepared to vaccinate the general population. In 2006, the Centers for Disease Control and Prevention (CDC) conducted an assessment, and the Alabama Department of Public Health Strategic National Stockpile (SNS) Plan received a 'Green' rating. For the past several years, ADPH SNS Program has conducted Points of Dispensing (POD) training. POD training allows staff and volunteers to practice various scenarios involving the possibility of a contagious public health crisis. Pandemic Influenza (PI) is the focus of the 2007 POD trainings. Two trainings have been conducted for volunteers from the civilian population. Two additional trainings will also be conducted for the Poarch Band of Creek Indians on their reservation and another for Maxwell Air Force Base personnel. In March 2007, an SNS exercise was conducted involving the transportation and security of antiviral medication from a Receiving, Storage, and Staging (RSS) site to other named receiving centers throughout the state. This exercise consisted of dividing boxes by population size, placing them on the trucks, and having armed security escort the product to county destinations. When the boxes were delivered to the five different catchment areas, the local Emergency Management Agencies (EMAs) then escorted distribution of the boxes to county health departments (CHD)."
Alabama. Department of Public Health
2007-04-16
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Department of Defense Directive 1035.01: Telework Policy
"This Instruction: Reissues Reference (a) as a DoD Instruction in accordance with the guidance in Reference (b) and the authority in Reference (c). Establishes an overarching policy governing telework within the Department of Defense as authorized by Reference (c). Assigns responsibilities for telework. Establishes the supervisors' and/or commanders' authority to assign official duties (including training) that may be performed via telework. Implements the provisions of Reference (d); Subtitles B, C, D, section 113, and Chapter 47 of 10 United States Code (U.S.C.) (Reference (e)); sections 101 and 206 of 37 U.S.C. (Reference (f)); and is consistent with Under Secretary of Defense for Personnel and Readiness (USD(P&R)) Memorandum, 'Department of Defense Telework Policy and Guide for Civilian Employees' (Reference (g))."
United States. Department of Defense
2007-04-03
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Pandemic Influenza: Best Practices and Model Protocols
"The topic of Pandemic Influenza planning and preparation for emergency and public service organizations will always be a dynamic issue for discussion. First and foremost, this document focuses on the need for a community to plan and prepare for a pandemic outbreak today. While it is unknown when a pandemic influenza outbreak will develop in this nation, it is beneficial to realize that these best practices and model protocols are applicable to other emerging infectious disease outbreaks (e.g., SARS, Smallpox) or an act of bioterrorism in a community. Completing planning and preparation efforts for a pandemic outbreak today will have multiple benefits and applications in a community tomorrow. One critical preparation issue for a service provider is knowing when to implement the community's pandemic plan. Service organizations typically implement operational plans based on specific 'trigger-points'. Whether it is dispatching the unit, responding to an emergency, or maintaining the community infrastructure, there is generally an event that causes the action plan to be initiated. For this reason, the Department of Homeland Security (DHS) is coordinating development of this guidance model by the United States Fire Administration (USFA) with the ongoing efforts of the Department of Transportation (DOT), the Department of Health and Human Services (HHS), and others."
United States. Department of Homeland Security
2007-04
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Kentucky Pandemic Influenza Preparedness Plan
"It is not a question of if but when another influenza pandemic will occur. Kentucky must be prepared for this and other types of public health emergencies. To lessen the impact of an influenza pandemic, the Kentucky Department for Public Health has created the Kentucky Pandemic Influenza Preparedness Plan to promote an effective response throughout the pandemic. The plan was originally drafted in 2002 but is being updated through a coordinated effort of the Kentucky Department for Public Health (KDPH), Kentucky Division of Emergency Management (KYEM), Kentucky Office of Homeland Security (KOHS), Kentucky Department of Education (KDE), Kentucky Department of Agriculture (KDA), Kentucky Department of Criminal Justice Training (DOCJT), Kentucky State Police (KSP), Chamber of Commerce, universities, local health departments and other partners and stakeholders. The plan is considered a 'living document' and will be updated with changes as needed. Some of the most diverse areas within the United States are in Kentucky. […] The Kentucky Pandemic Influenza Preparedness Plan serves as a guide for the state during the various pandemic phases. The goal of this plan is to prevent illness and death and preserve critical community infrastructures. The potential impact of a pandemic could be both medical and economic. It is important to respect the potential impact a pandemic poses to all parts of society. Because Mother Nature does not aim, all citizens of the Commonwealth are at risk during a pandemic. The Kentucky Department for Public Health serves as the lead in this type of event, but it will require coordination and collaboration with many state and community partners to effectively manage a pandemic. In order to adequately prepare, the Kentucky Department for Public Health encourages all sectors to participate in planning, exercising, and responding to pandemic influenza."
Kentucky. Department for Public Health
2007-04
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Tabletop Exercise (TTX): 'Outbreak 2007' - Pandemic Influenza Leadership Tabletop Exercise: March 28, 2007: After Action Report (AAR) [Berkeley, California]
From the Executive Summary: "Campus emergency preparedness involves a cycle of outreach, planning, capability development, training, exercising, evaluation, and improvement. Successful exercises lead to an on-going program of process improvements. This report is intended to assist the University of California, Berkeley (UCB) leadership, Emergency Management, Department Operations Centers (DOC) and collaborating agencies in striving for preparedness excellence by analyzing exercise results and: 1.) Identifying strengths upon which to maintain and build; 2.) Identifying potential areas for further improvement; and, 3.) Recommending exercise follow-up actions[.] The suggested actions in this report should be viewed as recommendations only. In some cases, the University may determine that the benefits of implementation are insufficient to outweigh the costs. In other cases, the University may identify alternative solutions that are more effective or efficient. The University leadership should review the recommendations and determine the most appropriate action and the resources needed (i.e., time, staff, and funding) for implementation."
University of California, Berkeley
2007-03-28
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'Outbreak 2007' Pandemic Influenza Leadership Tabletop Exercise
This is the situation manual (SITMAN) for a tabletop exercise intended to to engage and prepare campus, emergency response leadership, executives, management, and emergency response to collaboratively examine and identify gaps and vulnerabilities in the, development of the Pandemic Influenza Emergency Draft Response Plan. The SITMAN includes information such as a schedule of events, relevant background information, instructions for participants, exercise assumptions, scenarios and discussion points, and a map of the university campus.
University of California, Berkeley
2007-03-28
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Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes to Preexisting Law [Updated March 12, 2007]
From the Summary: "Authorities to direct federal preparedness for and response to public health emergencies are found principally in the Public Health Service Act (PHS Act), and are administered by the Secretary of Health and Human Services (HHS). Three recent laws provided the core of these authorities. P.L. 106-505, the Public Health Threats and Emergencies Act of 2000 (Title I of the Public Health Improvement Act), established a number of new programs and authorities, including grants to states to build public health preparedness. P.L. 107-188, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, was passed in the aftermath of the 2001 terror attacks. It reauthorized several existing programs and established new ones, including grants to states to build hospital and health system preparedness. P.L. 108-276, the Project BioShield Act of 2004, established authorities to encourage the development of specific countermeasures (such as drugs and vaccines for bioterrorism agents) that would not otherwise have a commercial market."
Library of Congress. Congressional Research Service
Lister, Sarah A.; Gottron, Frank
2007-03-12
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Pandemic Flu Planning: City Bureaus Aware of National Plans, March 2007
"This report documents work we did at the request of the U.S. Government Accountability Office, to check City officials' knowledge of Federal planning for a pandemic flu. [...]. Our objective was to survey appropriate City of Portland officials to assess the City's overall awareness, knowledge, and understanding of the Federal pandemic flu planning process. We limited our survey to four questions suggested by GAO and used by other local government audit offices in order to expedite reporting our results to GAO in a form useful to the agency. To accomplish our objective, we studied a City organization chart and contacted offices of responsible officials to test for awareness of planning needs, and to identify knowledgeable individuals. We conducted 20 telephone interviews of officials to ask them the survey questions. (Two other officials preferred to respond by email.) We documented contacts and completed interviews to the extent possible based on each respondent's knowledge. We conducted, and are reporting on, additional work not requested by the GAO. We reviewed the national plans, initial GAO plans for the national survey, and City policy for emergency management. We also discussed our work with the Multnomah County Auditor's Office, and conducted a follow-up interview with coordinating officials in the Office of Emergency Management to collect additional information about the City's planning and coordination processes."
Portland (Or.). Office of the City Auditor. Audit Services Division
2007-03-06
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Pandemic Influenza Employee Communication Plan
This document provides communication plans for general workplace planning. It has 4 different time periods, which highlight the actions which should be taken during various stages of a pandemic influenza outbreak.
King County (Wash.)
2007-03-06
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State of Texas Emergency Management Plan Annex H: Appendix 7: Pandemic Influenza Response
"Pandemic influenza will pose unique and long-standing challenges not common to other disasters. The goal of pandemic influenza preparedness and response is to limit the spread of the virus; to minimize serious illness, hospitalizations, and death; to sustain critical infrastructure; and to minimize social disruption in Texas as a result of pandemic influenza. The purpose of this appendix is to provide guidance in preparing for, identifying, and responding to pandemic influenza that affects the State of Texas. For purposes of state emergency planning, this plan is focused on preparing for human pandemic influenza. The state's Foreign and Emerging Animal Disease (FEAD) plan will apply when preparing for a coordinated response to zoonotic disease outbreaks, including avian influenza."
Texas. Division of Emergency Management
2007-03-05
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Guide for the Selection of Chemical, Biological, Radiological, and Nuclear Decontamination Equipment for Emergency First Responders
From the Document: "This second edition guide includes information intended to be useful to the emergency first responder community in the selection of decontamination techniques and equipment for CBRN [Chemical, Biological, Radiological and Nuclear] incidences. It includes an updated market survey of decontamination equipment technologies and commercially available decontamination equipment known to the authors as of November 2006. Brief technical discussions are presented that consider the principles of operation of the various technologies. Readers desiring additional technical information can obtain it from the extensive list of references that is included in appendix A and the equipment data sheets provided in the corresponding data sheets in the appendices."
United States. Department of Homeland Security
Fatah, Alim Ahmed; Arcilesi, Richard D., Jr.; O'Connor, Laurel E. . . .
2007-03
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Postentry Quarantine Manual for State Inspectors: Procedural Manual for State Inspectors Conducting Postentry Quarantine Duties
"The Postentry Quarantine (PEQ) Manual enables State inspectors to perform the following tasks: 1. Complete appropriate form for the Permit Unit (PPQ Form 546 only) 2. Complete appropriate forms for the Postentry Quarantine Unit (PEQU) 3. Conduct a survey of the growing site to determine whether to approve the site 4. Inspect postentered plant material during the growing period for pests (primarily plant pathogens). This manual covers procedures for conducting PEQ tasks beginning with the request to approve a growing site and ending with the release or refusal of the plant material."
United States. Animal and Plant Health Inspection Service
2007-03
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Laboratory Checklist for Pandemic Influenza Preparedness
This document discusses federal/state guidance or communications needed by clinical laboratories. Topics include checklists for laboratory personnel and staff, testing, service shortages, supply shortages, communications, and bio-safety.
Wisconsin State Laboratory of Hygiene
2007-03-01
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Pandemic Preparedness
"The threat is legitimate: The world is under a Phase 3 Pandemic Alert. Foremost are the concerted attempts to effect attitudinal changes in senior managers and workers now, rather than delaying until a pandemic event unfolds. Awareness and preparation become the foundation for mitigating the potential effects of pandemic flu. To postpone the revising of policies or waiting to implement critical programs until a pandemic outbreak manifests itself within the population of this or any other country is simply too late. The pre-event stage is the time to devote resources (human and/or monetary) in support of mitigation strategies. Existing evidence along with expert opinion points to the inevitability of a pandemic flu event. While the exact time of a pandemic outbreak, its geographical spread and length of duration, cannot be predicted with complete confidence, indicators tracked by the public health community give cause for concern. The pre-event stage is, in actuality, the lull before the storm and affords Private Sector leaders and business continuity planners the chance to position their organizations for survival. To do otherwise is a gamble where the wrong bet carries devastating consequences."
Homeland Defense Journal (Firm)
Lowe, William
2007-03
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Pandemic Influenza Page Update Email
Announcement of major updates to the LLIS.gov Pandemic Influenza page.
Lessons Learned Information Sharing (LLIS)
2007-02-21?
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Pandemic Influenza: Domestic Preparedness Efforts [Updated February 20, 2007]
From the Introduction: "This report discusses pandemic influenza in general, previous pandemics and their global and domestic impacts, and the possible impacts of another pandemic caused by the H5N1 avian flu strain. It also discusses WHO [World Health Organization] and U.S. preparedness plans and their context in broader emergency preparedness efforts. Finally, the report looks at a number of policy issues in pandemic influenza preparedness and response. While reference is made when relevant to global preparedness efforts and to animal health impacts, this report focuses on U.S. domestic public health preparedness and response planning, and the projected impacts of an influenza pandemic on Americans."
Library of Congress. Congressional Research Service
Lister, Sarah A.
2007-02-20
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Ethical Guidelines in Pandemic Influenza
From the Document: "This document provides ethical guidance that the Ethics Subcommittee of the Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC) proposes as a foundation for decision making in preparing for and responding to pandemic influenza. The document was developed in response to a request from CDC that the Ethics Subcommittee address ethical considerations (1) in vaccine and anti-viral drug distribution prioritization and (2) in the development of interventions that would limit individual freedom and create social distancing (in discourse on pandemic influenza, often referred to as non-pharmaceutical interventions). Although the issue of the duty of health care professionals to provide care during a pandemic was outside the scope of the request, the Ethics Subcommittee believes that this issue is of central importance in pandemic planning and response and should be addressed in a subsequent document. An equally relevant issue, but also beyond the scope of this document, is the importance of providing legal protections for health care providers who, during a declared public health emergency, may be asked to perform services outside of their usual realm of responsibilities or to administer interventions which are not yet scientifically validated."
Centers for Disease Control and Prevention (U.S.)
Kinlaw, Kathy; Levine, Robert A.
2007-02-15
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Highly Pathogenic Avian Influenza and Pandemic Influenza MEOP Supplement
Highly Pathogenic Avian Influenza (HPAI) is a virulent type of Avian Influenza that spreads rapidly through flocks and kills most birds within 48 hours. This document provides planning guidance and outlines operational concepts for a HPAI or Pandemic Influenza outbreak in Minnesota.
Minnesota
2007-02-09
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Nevada Pandemic Influenza Preparedness and Response Plan: Annex to the Mass Illness Plan
"This Pandemic Influenza Preparedness and Response Plan is a guide on how to prepare, detect, and respond to an influenza pandemic in the state of Nevada. This plan is written in accordance with guidelines set forth by the Centers for Disease Control and Prevention (CDC) and describes the emergency management concepts and structure under which the Nevada State Health Division (NSHD) may operate. The plan outlines the roles and strategies of NSHD in coordinating the public health response to a pandemic with local health authorities, the healthcare community, the federal government, and other key partners. Consistent with NSHD's mission 'to promote, preserve and protect the health of all Nevadans and visitors to the state through its leadership in public health and enforcement of laws and regulations pertaining to public health,' this plan provides a framework for NSHD pandemic influenza preparedness and response activities. The goal of these activities is to reduce the morbidity, mortality, and social and economic disruption caused by pandemic influenza. The plan is an annex to the NSHD Comprehensive Emergency Management Plan (CEMP) and is consistent with the U.S. Department of Health and Human Services Pandemic Influenza Plan, November 2005. Additionally, this plan may be utilized by local public health authorities as a guide for local pandemic influenza response. Finally, it may inform those who review it of the assumptions used for the development of this plan, the planning activities that must take place in developing a pandemic influenza response, the policies and authorities that regulate a pandemic influenza response and the appropriate actions that must be taken during each of the six phases of a pandemic."
Nevada. Health Division
2007-02-09
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Pandemic Influenza
This document briefly outlines the characteristics and challenges posed by pandemic influenza. "A pandemic is a global disease outbreak. An influenza pandemic occurs when a new influenza virus emerges for which there is little or no immunity in the human population, begins to cause serious illness and then spreads easily person-to-person worldwide."
North Dakota. Department of Health
2007-02-01?
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Airborne Infectious Disease Management: Methods for Temporary Negative Pressure Isolation
From the Introduction: "Hospital preparedness for bioterrorism and other public health emergencies such as emerging airborne infectious diseases requires strategic planning to ensure that all components of respiratory protection programs, including environmental controls, are in place for airborne infection isolation rooms (AIIRs). Hospitals have insufficient facilities to provide airborne infection isolation for large numbers of patients with airborne infectious diseases presenting in a short time period. However, AIIRs have been increased recently, due to requirements of National Bioterrorism Hospital Preparedness Program. [...] This guide will assist health care facility plant maintenance and engineering staff, in coordination with infection control professionals, to prepare for a natural or terroristic event, involving an infectious agent transmitted by airborne droplet nuclei. Examples of such agents include measles, varicella, and tuberculosis."
Minnesota. Department of Health
Anderson, Jeanne; Geeslin, Andrew; Streifel, Andrew
2007-02
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APHA's Prescription for Pandemic Flu
"APHA recommends key changes to the nation's strategy for preparing and responding to a flu pandemic to ensure the health and safety of all individuals. Among its top concerns is the need for additional resources for an already overburdened public health work force that may lack the resources to fully respond to a flu outbreak. Other needs include clear federal guidance on school closures, quarantine and occupational health in the event of a pandemic."
American Public Health Association
2007-02
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Akron Health Department Emergency Operations Plan: Disease Surveillance Annex
The purpose of the Disease Surveillance Annex is to provide for disease surveillance during an emergency/disaster area to ensure that public health is not compromised.
Akron (Ohio) Health Department
2007-02
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Community Strategy for Pandemic Influenza Mitigation
"This document provides interim planning guidance for State, territorial, tribal and local communities that focuses on several measures other than vaccination and drug treatment that might be useful during an influenza pandemic to reduce its harm. Communities, individuals and families, employers, schools, and other organizations will be asked to plan for the use of these interventions to help limit the spread of a pandemic, prevent disease and death, lessen the impact on the economy, and keep society functioning. This interim guidance introduces a Pandemic Severity Index to characterize the severity of a pandemic, provides planning recommendations for specific interventions that communities may use for a given level of pandemic severity, and suggest when these measures should be started and how long they should be used. The interim guidance will be updated when significant new information about the usefulness and feasibility of these approaches emerges."
United States. Department of Health and Human Services
2007-02
