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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing: Guidance for Industry
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
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Responding to Child Victims
of Human Trafficking
From the Document: "For this publication, State laws, including statutes, regulations, and policies, were collected from States, the District of Columbia, and U.S. territories to gain a sense of what efforts State agencies are specifically, legally required to make in response to minor victims of sex trafficking. The information collected shows that State laws require child welfare agencies to develop policies, procedures, and protocols for assessing and providing appropriate services to children and youth who are suspected victims of sex trafficking or commercial sexual exploitation. The laws also require State agencies to assist victims of trafficking in accessing services that can appropriately meet their unique needs, and this often requires child welfare agencies to collaborate with an array of community agencies."
United States. Department of Health and Human Services; United States. Administration for Children and Families; United States. Administration for Children, Youth, and Families . . .
2019-12
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Counterfeit Pharmaceutical Inter-Agency Working Group Report to the Vice President of the United States and to Congress
"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
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Managing Solid Waste Contaminated with a Category A Infectious Substance
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
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Lead Inspector General Quarterly Progress Report on U.S. Government Activities: International Ebola Response and Preparedness
"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
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Guide for Developing High-Quality School Emergency Operations Plans for K-12
"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
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After-Action Report: Outbreak Response and Bioterrorism Investigation: US-Romania-Moldova: Trilateral Forum and Tabletop Exercise
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
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Fourth Generation Agents: Reference Guide
"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
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Fourth Generation Agents: Medical Management Guidelines
"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
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Quick Reference: Radiation Risk Information for Responders Following a Nuclear Detonation
"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
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Federal Plans to Monitor Immunization Safety for the Pandemic 2009 H1N1 Influenza Vaccination Program
"Since the 2009 H1N1 influenza first was identified in the spring, the U.S. Department of Health and Human Services has worked in close partnership with virtually every part of the federal government under a national preparedness and response framework. With unprecedented speed, federal health officials collaborated with industry partners to produce, test, and license 2009 H1N1 influenza vaccines that ultimately will be made available to everyone who wants to get vaccinated. As with seasonal influenza, young children, persons with some chronic health disorders, and pregnant women have a higher risk of severe disease. Clinical trials and safety testing of H1N1 flu vaccines are a critical part of the federal government's H1N1 influenza response plans, and careful stewardship of vaccine safety is integral to maintaining public health and trust in the 2009 H1N1 influenza immunization program The 2009 H1N1 influenza outbreak poses unprecedented opportunities for collaboration and coordination of activities to monitor vaccine safety. A robust plan for monitoring adverse events following immunization during mass vaccination for 2009 H1N1 influenza is a critical component to ensure the safety of these vaccines. While the safety of 2009 H1N1 flu vaccines are anticipated to be similar to seasonal influenza vaccines, which have an excellent record, extensive efforts have been made to enhance safety systems for 2009 H1N1 influenza monitoring. The primary intent of these efforts is to accelerate the availability of safety data to inform the immunization program, health care providers, and the public."
United States. Department of Defense; United States. Department of Health and Human Services; National Institutes of Health (U.S.) . . .
2009
