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• The Exchange: COVID-19 and Healthcare Professional Stress and Resilience [Issue 12]

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  From the Foreword: "The phenomenal effort that you and other healthcare emergency readiness and response professionals have made while caring for this nation's communities during the COVID-19 [coronavirus disease 2019] pandemic has not gone unnoticed and ASPR [Assistant Secretary for Preparedness and Response] recognizes the immense sacrifices you and your peers continue to make. We also understand that responding to this long-term incident may affect your mental health, morale, and resilience. In this issue ASPR TRACIE [Technical Resources, Assistance Center, and Information Exchange] strives to collect and share the most valuable, timely, and helpful information for you and your colleagues and offer the following resources to address healthcare worker mental health and resilience: [1] The COVID-19 Behavioral Health Resource Collection includes a section on Self-Care and Resilience Resources for Responders and Healthcare Workers. [2] The Behavioral Health Compendium can help Regional Emergency Coordinators and federal and state planners better understand how programs with behavioral health components (e.g., steady state programs, grants, certain HHS [Health and Human Services] programs, waivers and flexibilities) can support the pandemic response. [3] ASPR TRACIE Mini Modules to Relieve Stress for Healthcare Workers Responding to COVID-19 are designed for healthcare workers in all settings, but primarily hospital-based providers, staff, and leaders dealing with the COVID-19 pandemic."

  United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Technical Resources, Assistance Center and Information Exchange

  2020
• Biosafety in Microbiological and Biomedical Laboratories; Fifth Edition

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  "Biosafety in Microbiological and Biomedical Laboratories (BMBL) quickly became the cornerstone of biosafety practice and policy in the United States upon first publication in 1984. Historically, the information in this publication has been advisory in nature even though legislation and regulation, in some circumstances, have overtaken it and made compliance with the guidance provided mandatory. We wish to emphasize that the 5th edition of the BMBL remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories, from a biosafety perspective and is not intended as a regulatory document; though we recognize that it will be used that way by some. During the latest revision of the BMBL additional sections were added; sections on the principles and practices of biosafety and on risk assessment were expanded; all agent summary statements and appendices were revised; and effort was made to harmonize recommendations with guidance issued and regulations promulgated by other federal agencies. Wherever possible, an attempt was made to clarify both the language and intent of the information provided. The events of September 11, 2001 and the anthrax attacks in October of that year re-shaped and changed, forever, the way we manage and conduct work in biological and clinical laboratories and draw into focus the need for inclusion of additional information in the BMBL."

  United States. Department of Health and Human Services; National Institutes of Health (U.S.); United States. Public Health Service . . .

  2007
• Mammography Quality Standards Act Final Regulations: Modifications to the Policy Guidance Help System Due to the September 11, 2001 Terrorist Attacks

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  This document is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration's (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539). The FDA uses mandatory language, such as shall, must, and require, when referring to statutory or regulatory requirements. The FDA uses non-mandatory language, such as should, may, can, and recommend when referring to guidance. It is the responsibility of the facility to read, understand, and follow the final regulations. Under its own authority, a State may impose more stringent requirements beyond those specified under MQSA and its implementing regulations. A facility may want to check with the State or local authorities regarding their requirements."

  United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Devices and Radiological Health (U.S.). Division of Mammography Quality and Radiation Programs

  2001-10-05
• Guidance for Industry and FDA Staff: In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency

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  "This document provides guidance on the type of information and data that FDA recommends you include in an Emergency Use Authorization (EUA) request for in vitro diagnostic (IVD) devices intended for use in diagnosing 2009 H1N1 Influenza virus infections during the emergency involving Swine Influenza A declared by the Secretary of the Department of Health and Human Services (HHS) on April 26, 2009 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Such devices will be referred to in this guidance as '2009 H1N1 tests.' […].This document applies to 2009 H1N1 tests while the declaration of emergency under § 564(b) of the FD&C Act concerning 2009 H1N1 Influenza (H1N1) is in effect. See 21 U.S.C. 360bbb-3(b)(2) regarding the termination of a declaration of emergency. FDA is issuing this level 1 guidance for immediate implementation consistent with the agency's good guidance practices regulation (21 CFR 10.115). FDA has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)) because the agency must act immediately to protect the public health during the declared emergency concerning 2009 H1N1 Influenza. The guidance represents FDA's policy for 2009 H1N1 tests that are already being offered for clinical use on the date the guidance is issued, as well as for any new 2009 H1N1 tests. The information contained in this guidance document should facilitate the submission of EUA requests for 2009 H1N1 tests to FDA by those who wish to pursue such requests."

  United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Devices and Radiological Health (U.S.). Office of In Vitro Diagnostic Device Evaluation and Safety

  2009-11-06
• Federal Strategic Action Plan on Services for Victims of Human Trafficking in the United States: Fiscal Years 2013-2014 Status Report

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  This status report lays out the status of all of the overarching themes and 8 objectives, in a table format. The corresponding report is here, https://www.hsdl.org/?abstract&did=749424.

  United States. Department of State. Bureau of Public Affairs; United States. Department of Homeland Security; United States. Department of Health and Human Services . . .

  2014?
• Fire Safety Program Toolkit: A Comprehensive Resource for Fire Safety Educators

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  "This toolkit was designed with fire safety education personnel in mind and aims to provide free tools and materials to assist in the development of educational programs. The toolkit breaks down the program development process into five basic steps to create or enhance a fire safety education program for your community. Additionally, a 'Beyond the Basics' in each section has even more resources, strategies, and tools. This overview gives you a snapshot of the process for developing a successful program." The five basic steps covered in this toolkit include the following: 1) Assess Your Community; 2) Develop Partnerships; 3) Plan & Implement Your Program; 4) Market Your Program, and 5) Evaluate.

  United States. Department of Health and Human Services; Centers for Disease Control and Prevention (U.S.); United States. Federal Emergency Management Agency . . .

  2015-02-05?
• Bought and Sold: Helping Young People Escape from Commercial Sexual Exploitation

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  This document concerns the commercial sexual exploitation of young people in the United States. Sections of the document include: (1) Some Youth Are More at Risk; (2) No One Chooses to Be Exploited; (3) Signs of Sexual Exploitation; (4) What Victims of Sexual Exploitation Need; (5) When to Involve Police; and (6) When to Tell the Youth's Family Members. "Prostitution. Pornography. Survival sex. Commercial sexual exploitation is more than just young people being sexually abused by adults. Perpetrators victimize young people by paying, or promising to pay, money, goods or services to a youth--or a pimp--in exchange for sexual acts or entertainment. The impact of commercial sexual exploitation on young victims is often devastating. Instead of attending school, they face violence, disease and jail. Before they are even old enough to vote, they lose their dignity and their freedom. They suffer emotional trauma that may never go away. Helping young people escape from exploitation should be a top priority of communities and youth workers everywhere."

  United States. Family and Youth Services Bureau; United States. Department of Health and Human Services; United States. Administration for Children and Families . . .
• Guidance on Initial Responses to a Suspicious Letter/Container with a Potential Biological Threat

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  "A large number of potentially suspicious letters and packages continue to be reported to federal, state, and local law enforcement and emergency response agencies nationwide. In some instances these letters or packages may include powders, liquids, or other materials. Federal, state, and local response agencies should be mindful of the potential for small-scale exposure, which could result from material contained in threatening or suspicious packages. While this guidance is generally focused on the initial response to potential biological threats, all personnel responding to such incidents must be aware of the potential for exposure to hazardous chemical and/or radiological materials in addition to biological hazards. Additionally, there may be a threat posed from secondary releases or devices. Consistent with established protocols, response agencies should follow standard law enforcement procedures and hazard risk assessments in response to calls, and should pre-identify the relevant local public health points of contact to be notified in the event of a potential bioterrorism event. The following guidelines are recommendations for local responders, based on existing procedures (including recommendations from the International Association of Fire Chiefs). This document provides guidance on the initial response to a suspicious letter/container, while other follow-on response plans, such as portions of the National Response Plan (NRP), may be utilized if a threat is deemed credible. In general, these potential threats or incidents fall into one of five general scenarios."

  United States. Department of Health and Human Services; United States. Federal Bureau of Investigation; United States. Department of Homeland Security . . .

  2004-11-02
• One Hundred Years of Federal Mining Safety and Health Research

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  "This publication provides an historical overview of research undertaken by the U.S. federal government over the last 100 years to improve the health and safety of our nation's miners. Federal research efforts began with the establishment of the U.S. Bureau of Mines (USBM, or the Bureau) in 1910. They have continued over the past century, even after the Bureau's closure in 1996. It is hoped that this publication will give the reader an appreciation for the work of mining health and safety researchers over the past century, and of the miners served by this research. Although not a comprehensive history, this report highlights the key organizational changes made within the Bureau and the federal government that affected mining safety and health research. Some mention is also made of Bureau research not directly related to mining health and safety. Note that the work classified as safety and health research has varied over the last century. For example, before 1970 the Bureau separated mining research and safety and health research. At that time, mining research included ground control and methane drainage because they had direct implications for mine safety. Explosives research was also reported separately from health and safety, even though permissible explosives research was obviously related to safety. Therefore, where budget figures from the Bureau are mentioned in this report, it is often not possible to separate safety and health research from other types of research. This history is generally chronological, with a few exceptions. Because of their prominence and direct links to Bureau research, most of the Public Health Service mining studies completed before 1970, when NIOSH [National Institute of Occupation Safety and Health] was established, will be discussed in a single section, even though the work spanned many decades. Likewise, for convenience, the brief histories of the Bureau's mining research centers are located in one section."

  United States. Department of Health and Human Services; National Institute for Occupational Safety and Health; Centers for Disease Control and Prevention (U.S.) . . .

  Breslin, John A.

  2010-02
• Attitudes Toward Mental Illness: Results from the Behavioral Risk Factor Surveillance System

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  "In 2005, the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA) collaborated to track state-level attitudes toward mental illness. Following recommendations from the 2002 President's New Freedom Commission on Mental Health, these agencies sought to examine public perceptions regarding treatment effectiveness and perceptions regarding people being caring and sympathetic to people with mental illness. This collaboration paralleled the release of a SAMHSA national anti-stigma campaign, What a Difference a Friend Makes, designed to help young adults support friends with a mental health problem. Two questions that asked about attitudes toward mental illness, along with other questions about mental illness symptoms, were included on the CDC-supported Behavioral Risk Factor Surveillance System (BRFSS). These questions comprised the BRFSS Mental Illness and Stigma Module. In 2007, 35 states, the District of Columbia, and Puerto Rico received SAMHSA support to collect data using the BRFSS Mental Illness and Stigma Module, and, in 2009, 16 states received support to do so. While a 2010 CDC study published in the 'Morbidity and Mortality Weekly Report' (CDC, 2010) described some limited findings, the goals of this study were to expand on the previous analysis to (1) provide state-level estimates of attitudes toward mental illness by select socio-demographic factors, mental illness symptoms, and mental health treatment; (2) examine individual (e.g., age, race/ethnicity) and state-level predictors (e.g., per capita expenditures on mental health services; the average annual unemployment rate; and exposure to the What a Difference a Friend Makes campaign) on attitudes toward mental illness; (3) highlight population subgroups who strongly disagree with the statements (i.e., a vulnerable group) for each state; and (4) provide resources and strategies for targeting these groups, and combating stigma in general. This study found that most adults (>80%) in the states surveyed agreed that mental illness treatment is effective, but substantially fewer adults (35%--67%) agreed that people are caring and sympathetic to people with mental illness. Some population subgroups (e.g., black, non-Hispanic adults, Hispanic adults, those with less than a high school education) were more likely to strongly disagree that treatment is effective."

  Centers for Disease Control and Prevention (U.S.); United States. Department of Health and Human Services; United States. Substance Abuse and Mental Health Services Administration . . .

  Kobau, Rosemarie; Zack, Matthew M.; Luncheon, Cecily

  2012
• Ready for Anything: A Disaster Planning Manual for Runaway and Homeless Youth Programs

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  "A successful response to disaster begins months, or even years, in advance, when you sit down to develop a plan. This manual is designed to help you construct that plan. In the following pages, you will have the opportunity to answer questions or complete worksheets. Various templates are also included in the appendices to add to your own disaster preparedness binder. […] All the preparation in the world will not matter if you do not also plan out the specific course of action you will take when a disaster strikes. Disasters bring with them chaos, confusion, and fear. The most effective way to combat these destructive elements is to have a clear, comprehensive, well-practiced response plan in place."

  United States. Department of Health and Human Services; United States. Administration for Children and Families; United States. Family and Youth Services Bureau . . .
• After Action Report: Southern Caucasus BioShield Workshop 2010: Public Health, Security, and Law Enforcement Partnership in Bio-Incident Pre-Planning and Response and Bioterrorism Tabletop Exercise

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  "The Southern Caucasus Workshop on 'Public Health, Security, and Law Enforcement Partnership in Bio-Incident Pre-Planning and Response' was held in Tbilisi, Georgia, 11-12 May 2010, pursuant to Georgia's request to the US Government for assistance on assessing the national (inter-sectoral), regional, and international unity of effort in response to potential biological incidents, and to prepare for the 2010 Biological Weapons Convention (BWC) meetings (which will address and promote common understanding and effective action on the provision of assistance and coordination with relevant organizations upon request by any State Party in the case of alleged use of biological weapons)." The workshop consisted of four main goals: "To foster improved understanding of the respective procedures and requirements of public health, security and law enforcement in response to a biological incident, and to enhance their joint effectiveness in pre-planning and response at the national and regional/international level"; "To enhance understanding of intergovernmental organizations' role and their interaction in the process of sharing information and coordinating response"; "To emphasize the concept that information exchange in the early stages of a biological incident is critical to effectively apprehending the potential perpetrators and containing the outbreak"; and "To review the existing legal and regulatory infrastructure of national measures consistent with the obligations under the BWC, UN Security Council".

  United States. Defense Threat Reduction Agency; United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; Centers for Disease Control and Prevention (U.S.)

  2010-05-12
• Food Related Emergency Exercise Boxed-set (FREE-B) Lead Planner's Guide

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  "To protect the health of the American public, it is crucial that we ensure that food products are safe for consumption. Everyone involved in the food chain, from farmer to consumer, has a responsibility to keep the food supply safe. [...] Each tabletop exercise has been designed by a group of subject matter and instructional design experts to provide participants with real-life, plausible food emergency related scenarios. While the scenarios have been simplified in order to present the information in an effective way, the scenarios and the discussion questions have been designed to encourage participant dialogue and surface topics that are critically important to reacting to such incidents. The exercises have also been developed to provide participants with an opportunity to explore important topics like interagency collaboration, jurisdictional issues and risk communication. The information in the scenarios reflects the policies and procedures currently in use and is accurate as of May 2011. If there has been an update to the procedures in your jurisdiction, please be sure to make the group aware of the change and work with the facilitator to ensure that all participants understand the update."

  United States. Department of Health and Human Services; Center for Food Safety and Applied Nutrition (U.S.); United States. Animal and Plant Health Inspection Service . . .

  2011-07-20
• Facing Addiction in America: The Surgeon General's Spotlight on Opioids

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  From the Disaster Information Management Research Center website: "This 40-page report assembles opioid-related information from Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health (2016) in one document, and provides updated data on the prevalence of substance use, opioid misuse, opioid use disorders, opioid overdoses, and related harms. It offers practical information and guidance that individuals and systems can use to take action to mitigate the opioid crisis."

  United States. Department of Health and Human Services; United States. Public Health Service. Office of the Surgeon General; United States. Substance Abuse and Mental Health Services Administration

  2018-09
• Ebola Outbreak 2014: Information Resources [website]

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  This National Library of Medicine website is about the 2014 Ebola outbreak and contains various resources concerning the outbreak. The purpose of this page is to provide individuals and organizations with information about the disease and resources available to those providing local and international services. Information resources include the following: 1) U.S. Federal Organizations; 2) U.S. Organizations; 3) International Organizations; 4) Free Resources from Publishers for Medical Responders; 5) Biomedical Journal Literature and Reports; 6) Social Media; 7) Health Resources for the Public; 8) Multi-Language Resources; and 9) Disclaimer.

  National Library of Medicine (U.S.). Disaster Information Management Research Center; National Library of Medicine (U.S.). Specialized Information Services Division; United States. Department of Health and Human Services
• Capacity-Building Toolkit for Including Aging & Disability Networks in Emergency Planning

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  "As natural and human-caused emergencies increase, the nation works to address the reality that emergencies do not discriminate in terms of impacted populations. Using the social determinants of health, it is possible to predict which populations are less likely to be prepared to effectively respond to, cope with, and recover from an emergency based on preexisting vulnerabilities. [...] The purpose of the Capacity-Building Toolkit for Including Aging and Disability Networks in Emergency Planning (hereafter, the 'Toolkit') is to serve as a resource to guide the aging and disability networks in increasing their ability to plan for and respond to public health emergencies and disasters. For organizations already engaged in emergency planning, this Toolkit can help expand and improve their capabilities. For organizations new to emergency planning, this Toolkit will help orient them to the process. Both goals are accomplished through content that guides programs that serve people with access and functional needs, including older adults and people with disabilities, through the emergency planning process of preparedness, response, recovery, and mitigation activities."

  National Association of County & City Health Officials (U.S.); United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; Association of State and Territorial Health Officials (U.S.)

  2019?
• Coordination, Collaboration, Capacity: Federal Strategic Action Plan on Services for Victims of Human Trafficking in the United States 2013-2017

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  From the document's Executive Summary: "This Plan details a series of coordinated actions to strengthen the reach and effectiveness of services provided to all victims of human trafficking, regardless of the victims' race, color, national origin, disability, religion, age, gender, immigration status, sexual orientation, or the type of trafficking they endured. The purpose of this Plan is to describe the steps that federal agencies will take to ensure that all victims of human trafficking in the United States are identified and have access to the services they need to recover. This includes steps to create a victim services network that is comprehensive, trauma-informed, and responsive to the needs of all victims. While prevention and prosecution activities fall outside the scope of this document, the Administration recognizes that addressing human trafficking through prevention, exploring and implementing demand reduction strategies, and using prosecution to hold offenders accountable are critical elements in the U.S. Government's comprehensive approach to combating all forms of human trafficking. The Plan focuses on providing and coordinating support for victims and it aligns with all other efforts of the Federal Government to eliminate human trafficking and prevent further victimization, particularly as outlined in the 'Attorney General's Annual Report to Congress and Assessment of U.S. Government Activities to Combat Trafficking in Persons.' […] Finally, the quality of the services, not merely the quantity, must be addressed to ensure that victims are supported throughout their long-term journey as survivors." The Plan includes introductory letters by President Barack Obama and Planning Co-Chairs Eric H. Holder, Jr. (Attorney General), Kathleen Sebelius (Secretary of Health and Human Services), and Jeh Charles Johnson (Secretary of Homeland Security).

  United States. Department of Justice; United States. Department of Health and Human Services; United States. Department of Homeland Security . . .

  2014-01
• Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities, December 2008

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  "The evaluation of safety for vaccines is conducted through a network of diverse, yet integrated activities that cuts across Federal agency responsibilities and includes the private sector and academic investigators. This document describes the United States vaccine safety system and articulates the roles and responsibilities of various agencies and their activities in evaluating vaccine safety. The development, licensure and widespread use of a vaccine involves activities and programs from a broad range of groups, including State health departments, academia, industry, healthcare providers, professional organizations, third party payers, managed care organizations, philanthropic and service organizations, and agencies within the Department of Health and Human Services (HHS), including the National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the National Vaccine Injury Compensation Program (VICP) in the Health Resources and Services Administration (HRSA). The Department of Veterans Affairs (VA), the Department of Defense (DoD), and international organizations such as the World Health Organization (WHO) also contribute to knowledge about vaccines and their widespread use. Ensuring vaccines are as safe as possible is the goal of these collective endeavors. Safety assessment is a continuous process. As new information becomes available about vaccine safety and efficacy, changes are made in manufacturing and/or recommendations for use."

  United States. Department of Health and Human Services; National Institutes of Health (U.S.); United States. Department of Veterans Affairs . . .

  2008-12
• Report to Congress: Coordinated Strategy to Accelerate Development of Vaccines for Infectious Diseases

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  "The purpose of the Tom Lantos and Henry J. Hyde United States Global Leadership against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293, is to strengthen and enhance U.S. leadership and the effectiveness of the U.S. response to the HIV/AIDS, tuberculosis, and malaria pandemics and other related and preventable infectious diseases as part of the overall U.S. health and development agenda. Section 206 of this law states: 'the President shall produce a comprehensive report, written by a study group of qualified professionals from relevant Federal agencies and initiatives, nongovernmental organizations, and industry representatives, that sets forth a coordinated strategy to accelerate development of vaccines for infectious diseases, such as HIV/AIDS, malaria, and tuberculosis, which includes: i. initiatives to create economic incentives for the research, development, and manufacturing of vaccines for HIV/AIDS, tuberculosis, malaria, and other infectious diseases; ii. an expansion of public-private partnerships and the leveraging of resources from other countries and the private sector; and iii. efforts to maximize United States capabilities to support clinical trials of vaccines in developing countries and to address the challenges of delivering vaccines in developing countries to minimize delays in access once vaccines are available.' This comprehensive report responds to this request. This report was compiled and edited by the congressionally mandated study group, which was set up for this purpose."

  United States. Department of Defense; United States. Department of Health and Human Services; United States. Agency for International Development . . .

  2009-10
• Evaluation of 2009 Pandemic Influenza A (H1N1) Virus Exposure Among Internal Medicine Housestaff and Fellows

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  "In August 2009, NIOSH [National Institute for Occupational Safety and Health] received an HHE [Health Hazard Evaluation] request from the director of the internal medicine residency program at UUSM [University of Utah, School of Medicine] concerning the exposure of internal medicine housestaff to the pH1N1 virus. A number of internal medicine housestaff were reportedly diagnosed with pH1N1 in June 2009, and more housestaff were reported to have ILI [Influenza-like illness], leading to significant absenteeism in this program. The exact extent of the disease, risk factors leading to infection, and modes of transmission among the internal medicine housestaff were unknown at the time of the request."

  Centers for Disease Control and Prevention (U.S.); United States. Department of Health and Human Services; National Institute for Occupational Safety and Health . . .

  de Perio, Marie A.; Brueck, Scott E.; Mueller, Charles A.

  2010-10
• Guidance to State and Local Governments and Other Federally Assisted Recipients Engaged in Emergency Preparedness, Response, Mitigation, and Recovery Activities on Compliance with Title VI of the Civil Rights Act of 1964

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  From the Document: "The United States Departments of Justice (DOJ), Homeland Security (DHS), Housing and Urban Development (HUD), Health and Human Services (HHS), and Transportation (DOT) are issuing this guidance to assist recipients of federal financial assistance engaged in emergency management (e.g., state and local emergency management agencies, law enforcement, healthcare service providers, housing and transit authorities) to ensure that individuals and communities affected by disasters do not face unlawful discrimination on the basis of race, color, or national origin (including limited English proficiency) in violation of Title VI of the Civil Rights Act of 1964 (Title VI)."

  United States. Department of Homeland Security; United States. Department of Justice; United States. Department of Housing and Urban Development . . .
• Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry

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  From the Introduction: "FDA [U.S. Food and Drug Administration] plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding: [1] Manufacturing controls to prevent contamination of drugs; [2] Risk assessment of SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] as it relates to drug safety or quality; [3] Continuity of manufacturing operations."

  United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Drug Evaluation and Research (U.S.) . . .

  2020-06
• Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and to Congress

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  "This Administration is focused on rebuilding the American economy, creating jobs, and increasing exports. To do so, we must be vigilant in enforcing our intellectual property rights. It is also of paramount importance to protect the public health. The U.S. has stringent statutory, regulatory and enforcement regimes to protect consumers against dangerous counterfeit, unapproved or illegally prescribed pharmaceuticals. However, increasing access to the Internet coupled with new methods of manufacturing and distributing illegal pharmaceuticals have created new challenges to safeguarding the legitimate pharmaceutical supply chain. Thousands of websites openly sell unapproved and/or counterfeit drugs, as well as prescription drugs without requiring a valid prescription, all in violation of federal and state law. Many of those sites are hosted by U.S. registrars, accept payment by U.S. payment processors, and shop their products via U.S.-based express courier companies or the U.S. Postal Service. In addition, other countries, particularly those in Africa, face extremely high percentages of counterfeits in their domestic supply chain and the United States is committed to helping them to address this scourge."

  United States. Department of Justice; United States. Department of State; United States. Department of Agriculture . . .

  2011-03
• Managing Solid Waste Contaminated with a Category A Infectious Substance

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  From the Preface: "[T]his guidance aims to prepare the nation to effectively manage Category A waste associated with infectious disease incidents. The guidance also aims to improve understanding of the safety of infectious waste management processes. It is intended to help government and non-governmental leaders, local emergency medical services, emergency managers, hospitals, healthcare providers, laboratories, environmental services workers, waste management companies and workers, and related stakeholders safely handle, inactivate, transport, and dispose of Category A waste."

  United States. Department of Transportation; United States. Environmental Protection Agency; United States. Department of Labor . . .

  2019-08
• Lead Inspector General Quarterly Progress Report on U.S. Government Activities: International Ebola Response and Preparedness

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  "On March 13, 2014, the Guinean Ministry of Health issued an alert concerning an unidentified disease and, together with the World Health Organization (WHO) and Médecins Sans Frontières (MSF, Doctors Without Borders), began an investigation into an outbreak of hemorrhagic fever. Laboratory tests subsequently confirmed that the outbreak was caused by the Ebola virus. On March 23, 2014, WHO announced the Ebola outbreak in Guinea and within days both Liberia and Sierra Leone reported possible cases of the Ebola virus disease (EVD). The Ebola virus is one of the most infectious viruses known, transmissible through contact with infected bodily fluids, and the resulting disease has a high case fatality rate. The case fatality rate for the current EVD outbreak in West Africa has been 70.8 percent. No cases of EVD had ever been previously recorded in West Africa, and the governments of Liberia, Sierra Leone, and Guinea had limited to no experience in identifying EVD cases or containing the disease. A rapid increase in the number of EVD cases and the spread of the disease in urban settings overwhelmed an already weakened healthcare system and diminished workforce. WHO reported a surge in EVD cases from approximately 132 reported cases in March 2014 to 1,440 cases in July 2014. By the end of July 2014, the Government of Liberia had shut down schools, quarantined communities most at risk, and used military personnel to enforce the quarantine."

  United States. Agency for International Development. Office of Inspector General; United States. Department of Defense. Office of the Inspector General; United States. Department of State. Office of the Inspector General . . .

  2015-03-31
• Guide for Developing High-Quality School Emergency Operations Plans for K-12

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  "Each school day, our nation's schools are entrusted to provide a safe and healthy learning environment for approximately 55 million elementary and secondary school students in public and nonpublic schools. Families and communities expect schools to keep their children and youths safe from threats (human-caused emergencies such as crime and violence) and hazards (natural disasters, disease outbreaks, and accidents). In collaboration with their local government and community partners, schools can take steps to plan for these potential emergencies through the creation of a school Emergency Operations Plan (school EOP). Lessons learned from school emergencies highlight the importance of preparing school officials and first responders to implement emergency operations plans. By having plans in place to keep students and staff safe, schools play a key role in taking preventative and protective measures to stop an emergency from occurring or reduce the impact of an incident. Although schools are not traditional response organizations, when a school-based emergency occurs, school personnel respond immediately. They provide first aid, notify response partners, and provide instructions before first responders arrive. They also work with their community partners, i.e., governmental organizations that have a responsibility in the school emergency operations plan to provide a cohesive, coordinated response. Community partners include first responders (law enforcement officers, fire officials, and emergency medical services personnel) as well as public and mental health entities. in public and nonpublic schools. Families and communities expect schools to keep their children and youths safe from threats (human-caused emergencies such as crime and violence) and hazards (natural disasters, disease outbreaks, and accidents). In collaboration with their local government and community partners, schools can take steps to plan for these potential emergencies through the creation of a school Emergency Operations Plan (school EOP)."

  United States. Department of Education; United States. Department of Health and Human Services; United States. Department of Homeland Security . . .

  2013
• After-Action Report: Outbreak Response and Bioterrorism Investigation: US-Romania-Moldova: Trilateral Forum and Tabletop Exercise

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  This After-Action Report provides material from the Trilateral (US-Romania-Moldova) Civilian-Military Forum, "Outbreak Response and Bioterrorism Investigation (ORBIT)". The main goals of this event were to: "1) promote interagency (in particular public health-law enforcement but also civilian-military) cooperation, coordination and synchronization for preparing, detecting, and responding to infectious disease outbreaks, whether natural, accidental, or deliberate in nature; 2) establish sustainable laboratory partnerships to enhance training and medical surveillance initiatives among the three countries; and 3) strengthen the core capacities required by the WHO [World Health Organization] International Health Regulations and existing national measures consistent with obligations under the Biological Weapons Convention and the UN [United Nations] Security Council Resolution 1540 to deter, prevent, and respond to biological incidents or threats."

  United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. European Command; Armed Forces Health Surveillance Center (U.S.) . . .

  2010-10-21
• Fourth Generation Agents: Reference Guide

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  "This guide was developed as part of ongoing preparedness for all hazards and is intended to inform decisions, protect emergency responders, and support response operations if an incident ever occurs involving a fourth generation agent (FGA, also known as A-series or Novichok nerve agents), such as the one used in the United Kingdom in 2018. No illicit use or manufacture of an FGA or other nerve agent is known to have occurred in the United States, and there is no known threat of any nerve agent use in the United States."

  National Library of Medicine (U.S.); United States. Department of Defense; United States. Department of Transportation . . .

  2019-01
• Fourth Generation Agents: Medical Management Guidelines

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  "These guidelines were developed as part of ongoing preparedness for all hazards and are intended to support fire, EMS [emergency medical services], and hospital staff in the medical management of patients if an incident occurs involving a fourth generation agent (FGA, also known as A-series or Novichok nerve agents), such as the one used in the United Kingdom (U.K.) in 2018. No illicit use or manufacture of an FGA or other nerve agent is known to have occurred in the United States (U.S.), and there is no known threat of any nerve agent use in the U.S. This document is divided into two sections: pages 5-7 include recommendations for fire and EMS responders and pages 8-11 include recommendations for hospital staff, with some repetition between the two. As part of ongoing standard preparedness, jurisdictions should update their existing plans with this information and integrate it into in-service training curricula."

  National Library of Medicine (U.S.); United States. Department of Defense; United States. Department of Health and Human Services . . .

  2019-01
• Quick Reference: Radiation Risk Information for Responders Following a Nuclear Detonation

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  "This document supports the 'Planning Guidance for Response to a Nuclear Detonation' and was designed to provide responders with specific guidance and recommendations about the radiation risk associated with responding to an improvised nuclear device (IND) event, in order for them to protect themselves from the IND effects. It is intended to be part of preparation training with the 'Health and Safety Planning Guide For Planners and Supervisors For Protecting First Responders Following A Nuclear Detonation'. This provides basic information responders will need for the first 24 -72 hours after an extreme event -- a nuclear detonation. These guidelines are not designed to apply to other, less extreme, radiological events. Specific information/training should be sought for those. Some of this guidance will be counterintuitive to those trained in emergency response; however, it is critical that responders remain as safe and healthy as possible, not only for their own safety, but also to remain available for the ongoing mission of saving lives. Responders involved in an IND event need to be prepared to see numerous victims with serious traumatic injuries and illness including: severe burns, blindness, deafness, amputations, radiation sickness, etc."

  United States. Department of Homeland Security; United States. Department of Energy; United States. Department of Health and Human Services . . .

  2016-12