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Providing Effective Services to Members of the LGBTQ2-S Community Following Disasters, Public Health Emergencies and Mass Fatality Events
"Disaster of all types disproportionately impact people in underserved and marginalized communities. Terrorist incidents such as the Pulse Night Club Shooting in June 2016 highlight the importance that emergency managers and all disaster responders increase their efforts to provide culturally competent disaster assistance to the Lesbian, Gay, Bisexual, Transgender, Questioning, Queer, Intersex, and Two-Spirit (LGBTQI2-S) community; particularly if the LGBTQI2-S community is targeted or impacted by a particular disaster."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-12-17
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NCHS Data Brief: Drug Overdose Deaths in the United States, 1999-2016
"Deaths from drug overdose are an increasing public health burden in the United States. This report uses the most recent data from the National Vital Statistics System (NVSS) to update trends in drug overdose deaths, describe demographic and geographic patterns, and identify shifts in the types of drugs involved."
National Center for Health Statistics (U.S.); Centers for Disease Control and Prevention (U.S.); United States. Department of Health and Human Services
Hedegaard, Holly; Warner, Margaret, 1965-; Miniño, Arialdi M.
2017-12
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NCHS Data Brief: Mortality in the United States, 2016
"This report presents final 2016 U.S. mortality data on deaths and death rates by demographic and medical characteristics. These data provide information on mortality patterns among U.S. residents by variables such as sex, race and ethnicity, and cause of death. Life expectancy estimates, age-specific death rates, age-adjusted death rates by race and ethnicity and sex, 10 leading causes of death, and 10 leading causes of infant death were analyzed by comparing 2016 and 2015 final data."
National Center for Health Statistics (U.S.); Centers for Disease Control and Prevention (U.S.); United States. Department of Health and Human Services
Kochanek, Kenneth D.; Xu, Jiaquan; Murphy, Sherry L. . . .
2017-12
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2017-2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan
"The '2017-2018 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan' (SIP) describes the priorities that the U.S. Department of Health and Human Services (HHS), in collaboration with its interagency partners, will implement over the next five years. [...] The annual PHEMCE SIP provides the blueprint the Enterprise will use to enhance national health security through the procurement and effective use of medical countermeasures (MCM). [...] HHS established the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) in July 2006, to coordinate federal efforts to enhance civilian MCM preparedness. The PHEMCE is responsible for coordinating the development, production, and availability of MCMs to limit potential adverse health impacts on the large and diverse U.S. civilian population. The PHEMCE works to meet the public health emergency needs of the entire civilian population, including those of groups that require special medical considerations, such as children, pregnant women, and older adults, as well as first responders, health care personnel, and other critical infrastructure personnel, by taking a whole-of-community approach in planning, response, and recovery efforts. It also seeks to leverage and coordinate with, as appropriate, efforts to address the needs of military populations, especially where product development efforts are parallel."
United States. Department of Health and Human Services
2017-12
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Tribal Nursing Home Best Practices: Emergency Preparedness
From the Document: "Across Indian Country, tribal nursing homes provide culturally sensitive long-term care environments where American Indian and Alaska Native elders can age with dignity and remain connected to their communities. Emergency planning is a crucial aspect of ensuring elders' comfort and safety. Many tribal nursing homes developed emergency preparedness plans to protect their residents in case of a natural disaster or other emergency. [...] A comprehensive, well-rehearsed emergency plan helps ensure that nursing home staff conduct evacuations and other emergency protocols efficiently to protect the safety of everyone involved. Having a plan in place reassures nursing home residents and their loved ones that they will remain safe in the event of an emergency. Many tribal nursing home emergency plans provide examples of culturally sensitive planning measures that other tribal facilities can emulate. This report describes the emergency preparedness approaches of five tribal nursing homes. It compiles emergency preparedness recommendations from nursing homes that have successfully created emergency plans and shares what has worked for these facilities, including leveraging partnerships, securing funding, and implementing staff training."
Centers for Medicare & Medicaid Services (U.S.); United States. Department of Health and Human Services
2017-12-01
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Highly Pathogenic Infectious Disease Exercise Planning for Health Care Coalitions
This is a webinar from the Office of the Assistant Secretary for Preparedness and Response (ASPR) of the Department of Health and Human Services. The Technical Resources, Assistance Center, and Information Exchange (TRACIE) is a clearinghouse for "information and technical assistance needs of regional ASPR staff, healthcare coalitions, healthcare entities, healthcare providers, emergency managers, public health practitioners, and others working in disaster medicine, healthcare system preparedness, and public health emergency preparedness." From the Welcome Message and Purpose: "[1] Management of patients with highly pathogenic infectious diseases is based on the regional, tiered approach set forth by ASPR for Ebola. [2] Health care coalitions are integral to a coordinated response among various partners in a region. [3] Planning and executing exercises for Ebola and other special pathogens assists health care coalition members in meeting various grant requirements."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-11-09
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National Framework for Personal Protective Equipment Conformity Assessment - Infrastructure.
"This Framework is the product of collaboration among the NIOSH [National Institute for Occupational Safety and Health] representatives and a broad cross-section of members of the PPE [personal protective equipment] community. This group's multi-year effort; (1) identified and analyzed national and international conformity assessment programs and requirements, (2) investigated injury and enforcement surveillance databases, (3) researched and gathered PPE standards, and (4) developed a risk-based approach to conformity assessment resulting in this Framework. [...] The recommendations in this document are intended to serve as foundational principles for various types of conformity assessment programs for occupational PPE. They are not requirements for how these programs must, or will , function. Conformity assessment activities should be tailored to the needs of product users, suppliers, and regulatory authorities. They should result in products that protect workers who rely on PPE; facilitate trade, fair competition, and market access; be cost-effective; and provide assurance of conformance."
National Institute for Occupational Safety and Health; Centers for Disease Control and Prevention (U.S.); United States. Department of Health and Human Services
D'Alessandro, Maryann
2017-11
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Mass Shooting/ No-Notice Incident After-Action Interview Guide: Medical Resource Requirements
From the Document, "This list of questions was used to help ASPR [Assistant Secretary for Preparedness and Response] TRACIE [Technical Resources, Assistance Center, and Information Exchange] staff interview various Las Vegas hospital personnel to collect and synthesize information from their mass shooting response. Results were used to develop a suite of No-Notice Incident Tip Sheets."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-11
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Decision Makers Guide: Medical Planning and Response for a Nuclear Detonation
From the Purpose: "This Manual will assist preparedness efforts and decision making by providing readily accessible information that quickly describes critical scientific and medical aspects of a nuclear incident as well as the response organization and resources anticipated to be required or available during a response. It is intended to offer a checklist of decision-provoking questions and reference guide for essential information to assist with the development of appropriate actions in response to a nuclear detonation. The subject matter includes basic principles about radiation, measurement, health effects, protective actions, critical public messaging, response strategies, medical management and countermeasures, and preparedness for a nuclear detonation."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-11
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Post-Disaster Lessons Learned: Dialysis Patient Management [October 11, 2017]
"ASPR [Assistant Secretary for Preparedness and Response] TRACIE [Technical Resources, Assistance Center, and Information Exchange] staff compiled resources and references related to post- disaster dialysis operations in response to numerous requests for technical assistance. We have also attached a previously completed technical assistance response on the post-Sandy improvements to dialysis patient management for additional reference."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Department of Health and Human Services
2017-10-11
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Healthcare System Recovery Timeline: A White Paper for Texas [October 11, 2017]
"Following a number of related technical assistance requests and in anticipation of future information needs from healthcare systems impacted by current and future disasters, ASPR TRACIE [Assistant Secretary for Preparedness and Response, Technical Resources, Assistance Center, and Information Exchange] developed this white paper to answer the question: 'How long does it take the healthcare system to recover from a major hurricane?' ASPR TRACIE conducted an extensive literature review of published and grey literature and open source media accounts of past disaster recovery reports. The results are presented below with findings and considerations listed first, followed by links to additional placed in an appendix."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Department of Health and Human Services
2017-10-11
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Major Hurricanes: Potential Public Health and Medical Implications [October 11, 2017]
"This ASPR [Assistant Secretary for Preparedness and Response] TRACIE [Technical Resources, Assistance Center, and Information Exchange] resource was developed to provide a short overview of the potential significant public health and medical response and recovery needs facing hurricane- and severe storm-affected areas, based on past experience and lessons learned from Hurricanes Katrina, Sandy, Harvey, and others."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Department of Health and Human Services
2017-10-11
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Avian Influenza (Including Asian H7N9): Resources at Your Fingertips
"This document provides healthcare system and public health preparedness professionals, emergency managers, and other stakeholders with resources and information to consider when improving their readiness for potential human infections with avian influenza A viruses. Significant concern exists about some avian influenza A viruses, including Asian lineage A(H5N1) and A(H7N9) viruses, that have caused sporadic human infections with high mortality, but no confirmed sustained human-to-human spread. These situations highlight possible issues for providers and planners, including: [1] Sporadic cases in the US among travelers returning from affected areas; [2] The possibility of an influenza pandemic resulting from a change in one of these viruses that would allow it to infect and transmit efficiently among people."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-10-06
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National Action Plan for Combating Antibiotic-Resistant Bacteria: Progress Report for Years 1 and 2
"Antibiotic Resistance (AR) is one of the most significant public health threats of our time. Every year, more than two million people in the United States are estimated to get infections that are resistant to antibiotics, and at least 23,000 people die as a result. At least another 15,000 deaths each year in the U.S. are caused by 'Clostridium difficile (C. difficile'), a bacterium that can cause serious diarrhea and that is often associated with antibiotic use. Many advances in medical treatment--like our ability to effectively treat patients with sepsis, cancer, organ transplants, burns, or trauma-- depend on the use of antibiotics to fight infections. If we lose effective antibiotics, the ability to safely offer people many life-saving and life improving modern medical advantages would be lost."
United States. Department of Health and Human Services; Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
2017-10
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Health and Social Services Disaster Recovery: Six Years in Retrospective, 2011-2017
From the Disaster Information Management Research Center website: "This 34-page document reports on the activities from 2011 to 2017 of the Department of Health and Human Services Division of Recovery, whose mission is to advance the nation's ability to recover from the health and social services effects of emergencies and disasters. It discusses National Disaster Recovery Framework (NDRF) Fundamentals, and details the division's responses to 14 emergencies and disasters, including hurricanes, tornadoes, flooding, drought, and contaminated water in Flint, Michigan."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-10?
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Zika: Resources at Your Fingertips [September 29, 2017]
"This document provides Zika virus disease resources and an overview of public health and healthcare system considerations and implications that are applicable to professionals in those systems, emergency management stakeholders, and other audiences. Appendix A contains resources from the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and relevant contact links. Appendix B includes citations with annotations for additional relevant resources and Zika Guidance. Finally, individuals can review ASPR TRACIE (Technical Resources, Assistance Center, and Information Exchange) Topic Collections, which provide a wide array of materials and resources for further research."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Department of Health and Human Services
2017-09-29
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HIPAA and Disasters: What Emergency Professionals Need to Know [September 11, 2017]
"Disasters and emergencies can strike at anytime with little or no warning and the local healthcare system in the midst of an emergency response can be rapidly inundated with patients, worried family and friends looking for their loved ones, and media organizations requesting patient information. Knowing what information can be released, to whom, and under what circumstances, is critical for healthcare facilities in disaster response. This guide is designed to answer frequently asked questions regarding the release of information about patients following an incident. NOTE: This guide does NOT replace the advice of your facility Privacy Officer and/or legal counsel who should be involved in planning for information release prior to an event, developing policy before a disaster that guides staff actions during a disaster, an"
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Department of Health and Human Services
2017-09-11
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U.S. Government Zika Vaccine Strategy
From the introduction: "To address the Zika virus public health threat, the Departments of Health and Human Services and Defense are coordinating efforts to help accelerate the development of Zika virus vaccines. Given the need for a vaccine to prevent disease caused by Zika notably including Congenital Zika Syndrome (CZS), these departments and their respective agencies (hereafter referred to as U.S. Government or USG) developed this Strategy in support of the following Goal and vaccine development Aims."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-09-07
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Recommendations for Incentivizing the Development of Vaccines, Diagnostics, and Therapeutics to Combat Antibiotic-Resistance
"The spread of antimicrobial resistance (AMR) is one of the most pressing public health problems facing the globe today. World leaders have recently acknowledged the growing threat of AMR; for example, the United Nations held a high-level meeting on AMR in September 2 016, and the Group of 20 (G20) released a declaration on combatting AMR in July 2017. Without interventions to curb the spread of AMR, it has been projected that by 2050, resistant infections will kill more people worldwide than cancer and cause global economic damage on par with the financial crisis of 2008. T he Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) was established in 2015 in consultation with the Secretaries of Defense, Agriculture, and Health and Human Services as part of a coordinated effort by the U.S. government to respond to this threat. In its 2015 report, Initial Assessments of the National Action Plan for Combating Antibiotic-Resistant Bacteria, PACCARB suggested that the current economic model is insufficient to ensure the availability of products and resources to fight AMR. Consequently, the PACCARB agreed to propose recommendations for incentivizing the development of new products to reduce the spread of AMR for both humans and animals."
United States. Department of Health and Human Services; Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
2017-09
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Human Trafficking: What Disaster Responders Need to Know
From the Document: "As a disaster responder and/or a healthcare provider, the likelihood that you will come in contact with a human trafficking victim is very high! Remember that anyone can be trafficked--men and boys, women and girls."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-09?
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Hurricane Resources at Your Fingertips [August 28, 2017]
"This document provides numerous hurricane-related resources applicable to a variety of stakeholders and audiences. Appendix A contains U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR)-specific resources and contact information. Appendix B includes all the citations with annotations if you'd like to dive deeper into a resource. ASPR TRACIE (Technical Resources, Assistance Center, and Information Exchange) Topic Collections provide a wide array of materials and resources for further research."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response; United States. Department of Health and Human Services
2017-08-28
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Final Report: Opioid Use, Misuse, and Overdose in Women
"Opioids, both illegal (e.g., heroin, illicitly manufactured synthetic opioids) and legal (e.g., oxycodone, hydrocodone) are drugs that reduce the body's perception of pain. The 'Diagnostic and Statistical Manual of Mental Disorders' (5th ed., 'DSM-5') defines opioid use disorder as a problematic pattern of opioid use leading to significant impairment or distress. Opioid use disorder is increasing at alarming rates for both men and women in the United States. While the epidemic is being addressed at many different levels, much still needs to be done. The prevalence of prescription opioid and heroin use among women is substantial. Between 1999 and 2015, the rate of deaths from prescription opioid overdoses increased 471 percent among women, compared to an increase of 218 percent among men, and heroin deaths among women increased at more than twice the rate than among men. Most alarmingly, there has been a startling increase in the rates of synthetic opioid-related deaths; these deaths increased 850 percent in women between 1999 and 2015. At the same time, the differences between how opioid misuse and use disorder impact women and men are often not well understood. Even in areas where differences between the sexes are apparent, such as women appearing to progress more quickly to addiction than men, very little is understood about why those differences occur. This Report highlights the key background and findings from the white paper, provides a summary of the September 2016 national meeting, and concludes with a section focused on findings and takeaways from both the national and regional meetings."
United States. Department of Health and Human Services. Office on Women's Health
2017-07-19
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Solar Eclipses: Planning Resources
"On August 21, 2017, a total solar eclipse will be visible in a path across the U.S. from Oregon to South Carolina, from early morning through the afternoon. It is expected that millions will travel to locations across the country to view this rare event. […] Many of these locations are rural with limited healthcare infrastructure, and since these sites are not (yet) officially sponsored, the typical augmentation of resources that accompanies planned mass gatherings will not take place. To address planning and response concerns and help local emergency healthcare providers plan for these gatherings, the ASPR TRACIE [Assistant Secretary for Preparedness and Response; Technical Resources, Assistance Center, and Information Exchange] team collected the following fact sheets, checklists, locally-developed guidance documents, and news articles on eye safety, injury treatment, and planned mass gatherings in rural and urban areas. Resources in sections I through V are specific to the eclipse event; the rest of the sections include resources related to planned mass gatherings."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-07
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HHS's Office of Refugee Resettlement Improved Coordination and Outreach to Promote the Safety and Well-Being of Unaccompanied Alien Children
"Each year, tens of thousands of children without legal status enter the United States unaccompanied by their parents or legal guardians. These children are referred to as unaccompanied alien children (UAC). Between fiscal years 2012 and 2016, the number of UAC entering the United States increased dramatically. Concern for the safety and well-being of these children after their release from Federal custody has risen in recent years, especially in response to instances of human trafficking. In response to the influx and ongoing concerns, this Office of Inspector General (OIG) report follows up on a 2008 report on the placement, care, and release of UAC. In the 2008 report, OIG found a lack of clarity between the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS) regarding their roles and responsibilities related to UAC. OIG also found that at the time neither Department checked on children's safety and well-being after their release from Federal custody. OIG recommended that the Departments delineate their roles and responsibilities in a formal agreement."
United States. Department of Health and Human Services. Office of Inspector General
Levinson, Daniel R.
2017-07
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Disaster Preparedness to Promote Community Resilience: Information and Tools for Homeless Service Providers and Disaster Professionals - Introduction to Promoting Community Resilience
"Individuals and families experiencing homelessness are among the most vulnerable members of our society. Many depend on an array of services to meet their basic needs on a daily basis. These services are provided by a range of community homeless service providers, consisting of shelters, meal providers, transitional housing facilities, health care providers and case management agencies. [...] Enhancing preparedness and continuity planning for healthcare providers and homeless service providers can assist in reducing potential interruptions of services. By maintaining service delivery, these institutions can care for their current clients while also functioning as a critical resource to homeless individuals when emergency managers and other government responders are likely to be overwhelmed with demands from the larger community (California Governor's Office of Emergency Services (Cal OES) 2000). [...] Agencies responsible for disaster planning within a jurisdiction (city, county, state, territory) must plan to care for the whole community. [...] Building an inclusive emergency management system that incorporates homeless service providers and health organizations as partners can dramatically improve disaster response for the entire community. Working as an inclusive system will also more adequately address the needs of individuals who are homeless and other at-risk populations. Ultimately, preparing homeless service providers, enhancing health care preparedness, and strengthening the emergency management system can increase community resilience to disasters. Healthcare system disaster planning can also ensure that homeless individuals, who often use emergency rooms for health care, receive needed care when demand on the system surges during disasters and avoid unnecessary strain on emergency medical systems. Healthcare settings will also be better able to respond with providers experienced in serving individuals experiencing homelessness, and able to expand such services after a disaster."
United States. Department of Veterans Affairs; United States. Department of Health and Human Services; United States. Department of Housing and Urban Development
2017-07
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EMS & Infectious Diseases: Challenges & Resources for Provider Protection [presentation]
From the Objectives: "[1] Discuss challenges to the EMS [emergency medical services] community related to infectious disease; [2] Introduce ASPR [Assistant Secretary for Preparedness and Response] TRACIE's [Technical Resources, Assistance Center, and Information Exchange] EMS Infectious Disease Playbook; [3] Improve knowledge of resources available to EMS dispatchers, providers, and physicians."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-06-22
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Emergency Preparedness Final Rule Interpretive Guidelines and Survey Procedures, Appendix Z
From the Document: "On September 16, 2016, the final rule on Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers was published (Federal Register Vol. 81, No. 180). This rule affects all 17 provider and supplier types eligible for participation in Medicare. The rule became effective on November 15, 2016 and will be implemented on November 15, 2017. [...] An advanced copy of the interpretive guidelines and survey procedures is available and will be incorporated into the SOM [State Operations Manual] under Appendix Z and applies to all 17 provider and supplier types. Since the Conditions of Participation (CoPs), Conditions for Coverage (CfCs) and requirements apply across providers and suppliers and only vary slightly, CMS [Centers for Medicare & Medicaid Services] has compiled the requirements under one appendix."
United States. Department of Health and Human Services; Centers for Medicare & Medicaid Services (U.S.)
2017-06-02
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Step Care for Ebola/Viral Hemorrhagic Fever Patients: Guidance for International Field Hospitals
"This document is intended to help organizations who want to provide care for Ebola virus disease (EVD)/viral hemorrhagic fever (VHF) patients determine an appropriate level of medical care that they can provide and anticipate the supplies that may be needed. This guidance may be applicable to other diseases where dehydration and electrolyte imbalance are key contributors to mortality. [...] This guidance provides suggested levels of medical care, as well as potential necessary supplies for patient care using a tiered approach. It is not designed to be comprehensive, and the resources available in the affected country, as well as supply chain integrity, will affect supply decisions. It does not account for the resources needed to support team members and suspect or convalescent isolated patients, nor does it consider the communications, command, and coordination elements that are critical to a successful mission. This guidance also does not cover infection control; training; site layout, including intake/assessment, suspect case testing, patient care (which may be organized by levels), feeding areas, convalescent care, and visiting areas; behavioral health; or other issues necessary for a safe and successful mission. The care of specialized populations, such as pediatric or obstetric patients, may require different expertise and resources, as well as specific changes to clinical care."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-06
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EMS Infectious Disease Playbook
"This document was created using official or best practice information taken from multiple organizations that was vetted and assembled by subject matter experts working for the Technical Resources, Assistance Center, and Information Exchange (TRACIE) at the request of the U.S. Department of Health and Human Services (HHS)/Office of the Assistant Secretary for Preparedness and Response (ASPR). The aim was not to develop novel guidance for emergency medical services (EMS) agencies, but to unify multiple sources of information in a single planning document addressing the full spectrum of infectious agents to create a concise reference resource for EMS agencies developing their service policies. This document does not represent official policy of HHS/ASPR or other federal or private agencies."
United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
2017-06?
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Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles: Draft Guidance for Government Public Health and Emergency Response Stakeholders
From the Document: "This guidance provides background information on the doxycycline drug product, the recommended protocol to support extending the expiration dates of specific doxycycline lots, how to identify a suitable laboratory to conduct testing, and the process for requesting and receiving an authorized expiration date extension for an identified lot of doxycycline. The criteria for an authorized extension include the requirements and conditions under section 564A(b) of the FD&C [Federal Food, Drug, and Cosmetic] Act for any expiration date extensions authorized by FDA [Food and Drug Administration] based on testing conducted following this guidance. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non-emergency purpose."
United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Drug Evaluation and Research (U.S.)
2017-04
