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Knowledge Library: Government Documents
ASPR | CDC | CRS | DHS | FDA | GAO | HHS | IOM | | NAS | NBAS | NSC | White House | WHO
ASPR
Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA
ASPR, 2010: The main goal of the Framework is to minimize the risk that unauthorized individuals or individuals with malicious intent will obtain “toxins and agents of concern” through the use of nucleic acid synthesis technologies, while simultaneously minimizing any negative impacts on the conduct of research and business operations.
CDC
2011 State Lab Preparedness
CDC, 2011: This fourth CDC preparedness report presents data on trends and documents progress in 2 important preparedness activities occurring at U.S. state and local health departments and includes individual fact sheets on activities occurring from 2007 to 2010 in the 50 states and 4 directly funded localities.
National Strategic Plan for Public Health Preparedness and Response
CDC, 2011: Released in September 2011, this 8-page plan is a guide for CDC, the public health system, and its stakeholders to secure the health of the nation and attain the plan’s collective 2020 vision of "people’s health protected—public health secured."
Public Health Preparedness: Strengthening the Nation’s Emergency Response State by State
CDC, 2010: This report highlights progress in preparedness, and presents data on a broad range of preparedness and response activities occurring at state and local levels across the nation. It includes national data and individual fact sheets for the 50 states and 4 directly funded localities.
CRS
Federal Efforts to Address the Threat of Bioterrorism: Selected Issues and Options for Congress
Congressional Research Service, 2011: This report focuses on 4 areas under congressional consideration deemed critical to the success of the biodefense enterprise: strategic planning; risk assessment; surveillance; and the development, procurement, and distribution of medical countermeasures. The report also focuses on the effectiveness and sufficiency of programs implementing these aspects of the federal biodefense efforts, provides outside analysts’ suggestions for improving the government’s efforts, and notes current issues under Congressional consideration.
DHS
National Response Framework
DHS, 2008: The National Response Framework is a guide to how the United States conducts all-hazards response, and is intended to capture specific authorities and best practices for managing incidents that range from the serious but purely local, to large-scale terrorist attacks or catastrophic natural disasters. In addition to the core document, the framework contains Emergency Support Function (“ESF”) Annexes, which group federal resources and capabilities into functional areas to serve as the primary mechanisms for providing assistance at the operational level. Common roles of federal agencies during emergencies are grouped together into 15 ESFs with different responsibilities based on these roles. Within each ESF there is at least one Primary Agency, Support Agencies, and an ESF Coordinator that is selected to oversee the ESF.
FDA
Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century
FDA, 2011: This outline of goals and priority areas to guide the FDA from 2011–2015 and beyond focuses on advancing regulatory science and innovation, strengthening the safety and integrity of the global supply chain, strengthening compliance and enforcement activities to support public health, expanding efforts to meet the needs of special populations, and advancing medical countermeasures. It also outlines long-term objectives, such as advancing food safety, and plans for implementing all strategic goals.
GAO
Homeland Security: Challenges for the Food and Agriculture Sector in Responding to Potential Terrorist Attacks and Natural Disasters
GAO, 2011: An examination of the nation’s ability to respond to and recover from potential terrorist attacks and natural disasters affecting food and agriculture.
National Preparedness: DHS and HHS Can Further Strengthen Coordination for Chemical, Biological, Radiological, and Nuclear Risk Assessments
GAO, 2011. The GAO's January–June 2011 performance audit, on which this report is based, assesses DHS and HHS coordination in preparing for chemical, biological, radiological, and nuclear (CBRN) threats.
National Preparedness: Improvements Needed for Acquiring Medical Countermeasures to Threats from Terrorism and Other Sources
GAO, 2011: Through the interagency Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), HHS leads federal efforts to develop and acquire medical countermeasures for terrorist and others threats posed by chemical, biological, radiological, and nuclear (CBRN) agents. This report examines how PHEMCE developed priorities for developing and acquiring CBRN countermeasures, improved acquisition and development, and coordinated these activities internally.
Biosurveillance: Efforts to Develop a National Biosurveillance Capability Need a National Strategy and a Designated Leader
GAO, June 2010: A robust and integrated national biosurveillance capability provides early detection and situational awareness of potentially catastrophic biological events; this report addresses federal efforts in support of that capability and the extent to which mechanisms exist to guide further development.
HHS
United States Government Policy for Oversight of LIfe Sciences Dual Use Research of Concern
National Institutes of Health, March 2012: The purpose of this Policy is to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.
Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight
HHS and Department of Agriculture, June 2009: This task force was established to analyze the current framework for research oversight activities involving infectious agents and toxins in high and maximum containment research facilities and to recommend improvements that could be made without hindering the progress of science.
National Health Security Strategy of the United States of America
HHS, 2009: To mitigate the effects of significant health events, this first National Health Security Strategy put forth a vision for health security that is built on a foundation of community resilience: healthy individuals, families, and communities with access to health care and the knowledge and resources to know what to do to care for themselves and others in both routine and emergency situations.
IOM
Advancing Regulatory Science for Medical Countermeasure Development—Workshop Summary
Institute of Medicine, 2011: Because conventional clinical trials may be unethical or impractical for gauging the safety of medical countermeasures that may be used in new ways in disasters, this report addresses ways to advance regulatory science for vaccines, medications, and diagnostics that may be used in response to public health emergencies.
Medical Countermeasures Dispensing: Emergency Use Authorization and the Postal Model—Workshop Summary
Institute of Medicine, 2010: This report summarizes an IOM workshop on rapid distribution and dispensing of medical countermeasures during time critical events (eg, following an anthrax attack), with special focus on the potential use of the U.S. Postal Service during such an emergency. It also summarizes advances in the FDA Commissioner’s authority to approve the use of unlicensed medical products or to approve off-label uses of approved medical products during an emergency.
NAS
Understanding Biosecurity: Protecting Against the Misuse of Science in Today’s World
National Academy of Sciences, 2010: An introduction to issues relating to misuse of the life sciences, illustrated through short case studies that highlight the challenges in striking the right balance between the exchange of scientific information and the potential for its misuse. Included is a review of strategies used to promote scientific development while safeguarding against its malevolent use and a list of useful resources.
NBAS
Improving the Nation’s Ability to Detect and Respond to 21st Century Urgent Health Threats: Second Report of the National Biosurveillance Advisory Subcommittee
National Biosurveillance Advisory Subcommittee, 2011: NBAS identifies specific recommendations for enabling the rigorous and effective biosurveillance essential to both management of catastrophic health events and routine public health practice and disaster response.
NSC
National Strategy for Counterterrorism
National Security Council, The White House, 2011: This document sets forth the U.S. approach to disrupting, dismantling, and eventually defeating al-Qa‘ida and its affiliates and adherents to ensure the security of U.S. citizens and interests. The Strategy maintains a focus on pressuring al-Qa‘ida’s core, while emphasizing the need to build foreign partnerships and capacity, and to strengthen our resilience.
National Strategy for Countering Biological Threats
National Security Council, The White House, 2009: Released in December 2009, this document outlines the President’s vision for addressing the challenges of proliferation of biological weapons or their use by terrorists. It highlights the beneficial nature of advances in the life sciences and their importance in combating infectious diseases of natural, accidental, and deliberate origin. It also outlines how the risks associated with misuse and the potential consequences of a biological attack require tailored actions to prevent biological threats. It specifically emphasizes the need to (1) improve global access to the life sciences to combat infectious disease regardless of its cause; (2) establish and reinforce norms against the misuse of the life sciences; and (3) institute a suite of coordinated activities that collectively will help influence, identify, inhibit, and/or interdict those who seek to misuse the life sciences.
The White House
National Security Strategy
The White House, 2010: The May 2010 National Security Strategy released by The White House establishes a strategic approach for advancing American interests, including the security of the American people, and an international order to address 21st century challenges. The Strategy reflects a clear understanding of our increasingly interconnected world in which the free flow of information, people, and goods is accelerating at an unprecedented pace and promising new opportunities, while simultaneously posing challenges that no longer recognize borders—global networks of terrorists and criminals, threats in space and cyberspace, a degrading climate, and technologies with tremendous destructive power.
President’s Memorandum on Science Integrity
The White House, 2009: This memorandum assigns responsibility for ensuring the highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological processes to the Director of the Office of Science and Technology Policy (OSTP).
World Health Organization
Early Warning Surveillance and Response in Emergencies
WHO, 2011: This report on a technical workshop designed to strengthen disease surveillance in the immediate aftermath of acute emergencies using the early warning alert and response network (EWARN) mechanism highlights the system's use in response to disasters in Haiti and Pakistan in 2010.
International Health Regulations
WHO, 2005: The stated purpose and scope of the IHR are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." They have been implemented by 194 countries in response to the exponential increase in international travel and trade, and the emergence and reemergence of international disease threats and other health risks.
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