Preparedness Pulsepoints

January 10, 2017

Public Health & Healthcare Preparedness

GUIDANCE
Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight. The intent of this document is to recommend consistent and appropriate Federal agency review and reporting processes for the enhanced oversight of Federally funded research that is anticipated to create, transfer, or use enhanced pathogens with pandemic potential. (The White House, 1/9/17)

See also: Blog - Recommended Policy Guidance for Potential Pandemic Pathogen Care and Oversight (The White House, 1/9/17)

NOTICE
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability. The Food and Drug Administration is announcing the issuance of an Emergency Use Authorization for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. (Federal Register, 1/9/17)

NEWS
FDA Backs Down from Releasing Genetically Modified Mosquitoes After Lawsuit Threatened. When the US Food and Drug Administration announced that it was dropping plans to release millions of genetically engineered mosquitoes in Key Haven, Florida, many people breathed a sigh of relief. (Florida Record, 1/8/17)

REPORT
Morbidity & Mortality Weekly Report. Often called "the voice of CDC," the MMWR series is the agency's primary vehicle for scientific publication of timely, reliable, authoritative, accurate, objective, and useful public health information and recommendations. (CDC, 1/6/17)

BLOG
Do You Know Who in Your Community is Most At-Risk in a Disaster? When a disaster strikes, it can harm the health of anyone in your community. However, some people are less likely to weather the storm because they may have certain medical conditions, are not able to get the help they need, or because they rely on others for help. (ASPR, 1/6/17)

PERSPECTIVE
Repealing the ACA without a Replacement - The Risks to American Health Care. President Barack Obama explains why the approach of "repeal first and replace later" is irresponsible - and could slowly bleed the health care system that all of us depend on. (New England Journal of Medicine, 1/6/17)

NOTICE
Emerging Tick-Borne Diseases and Blood Safety; Public Workshop. The Food and Drug Administration (FDA) is announcing a public workshop entitled "Emerging Tick-Borne Diseases and Blood Safety." The purpose of the public workshop is to discuss tick-borne pathogens that continue to emerge as threats to blood safety, the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions. (Federal Register, 1/5/17)

MEMORANDUM
Exit Memo: Department of Health and Human Services. The Department has met the challenges of new and unexpected public health issues, such as H1N1, the opioid crisis, Ebola, and Zika, that emerged during President Obama's time in office. In this memo, Sec. Sylvia Matthews Burwell outlines some of the progress that our nation has made during the past eight years and highlight some of the steps ahead to continue to build on that progress. (The White House, 1/5/17)

NEWS
Tightened Rules for Antibiotics for Food Livestock Go Into Effect. Under the Food and Drug Administration policy, antibiotics that have been designated "medically important" - in other words, they're needed to treat people - cannot legally be given to healthy animals to speed their growth. (STAT News, 1/3/17)

NEWS
For 1st Time, Government Includes Spread of Antibiotic-Resistant Bacteria in Injury Report. The federal government has cut payments to 769 hospitals with high rates of patient injuries, for the first time counting the spread of antibiotic-resistant germs in assessing penalties. (TribLive, 1/2/17)

WEBINAR
CDC's Antibiotic Resistance Investment Map. This webinar will cover the importance of antibiotics and the threat of antibiotic resistance, offer a brief overview of CDC antibiotic resistance investment strategies, and walk through the new AR investment map. The webinar will take place on January 12, 1-2 PM EST. Registration is required. (CDC, 1/17)

MEETING
Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The January public meeting will be dedicated to presentations from non-federal stakeholders surrounding the topic area of infection prevention and control. The meeting will take place on January 25, 2017 from 9:30 AM-5 PM EST. (Department of Health & Human Services, 1/17)

CALL FOR PAPERS
Evolution of Public Health Emergency Management. The American Journal of Public Health, in collaboration with the Centers for Disease Control and Prevention (CDC), intends to publish a supplement issue that will showcase the emergence of public health emergency management as a discipline in the United States since September 11, 2001, by highlighting innovative and effective evidence, strategies, solutions, and policies to achieve functional public health emergency management programs with demonstrated preparedness capabilities. (AJPH, 1/17)

REPORT
2016 PHEMCE Strategy and Implementation Plan. The 2016 PHEMCE Strategy and Implementation Plan (SIP) updates the 2014/2015 PHEMCE SIPs and provides the blueprint for the PHEMCE to enhance national health security through the development, procurement and planning for effective use of critical medical countermeasures. (ASPR, 1/17)

WEBINAR
ASPR TRACIE Webinar. Register for this webinar to learn more about the 2017-2022 Health Care Preparedness and Response Capabilities. The webinar will take place on January 11, 2017, from 2:30-3:30 PM EST. (ASPR, 1/17)

PRESS RELEASE
CDC Highlights Significant Contributions in the Fight Against Zika in 2016. T o respond effectively, new public health surveillance and infection control tools were developed that will reduce the effect of Zika virus infection on children and families and will provide a foundation for continued efforts to fight the disease. (CDC, 12/30/16)

See also: Zika Virus -10 Public Health Achievements in 2016 and Future Priorities (MMWR, 1/6/17)

NEWS
The CDC's New Quarantine Rule Could Violate Civil Liberties. The proposed regulation could be used to detain people without due process, or examine them without informed consent. (The Atlantic, 12/30/17)

PODCAST
The Nation's Disease Detective: Dr. Thomas Frieden. CSIS interviews Dr. Thomas Frieden, Director of the US Centers for Disease Control and Prevention (CDC), as he reflects on his tenure at CDC and current global health issues. (CSIS, 12/20/16)

See also: More Work Lies Ahead to Fight Zika, Other Threats - CDC Chief (Reuters, 12/30/16)

NEWS
CDC Concludes Inspection of Lab That Supplied Ricin; Matter Under Review. The Federal Emergency Management Agency's Center for Domestic Preparedness has placed the blame on the lab for a mix-up that resulted in thousands of civilian first responders at the Anniston center since 2011 unknowingly training with the toxic version of ricin, rather than a less toxic version the CDP has said was ordered. (Anniston Star, 12/29/16)

See also: CDC Keeps Secret its Mishaps with Deadly Germs (USA TODAY, 1/4/17)

WORKSHOP
Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products. The purpose of the public workshop is to have a scientific discussion of the current methods available for identifying and characterizing infectious disease risks associated with human cells, tissues, and cellular and tissue-based products. (FDA, 12/29/17)

RESEARCH
Detection of Ebola Virus RNA through Aerosol Sampling of Animal Biosafety Level 4 Rooms Housing Challenged Nonhuman Primates. Researchers at the US Army Medical Research Institute of Infectious Diseases demonstrate that the BSL-4 suit protects workers from aerosols in a BSL-4 environment using proper engineering and administrative controls. (Journal of Infectious Diseases, 12/23/16)

Homeland Security & Disaster Preparedness

STATEMENT
Designation of Election Infrastructure as a Critical Infrastructure Subsector. Sec. Jeh Johnson has determined that election infrastructure in this country should be designated as a subsector of the existing Government Facilities critical infrastructure sector. (Department of Homeland Security, 1/6/17)

MEMORANDUM
Exit Memo: Department of Homeland Security. Sec. Jeh Johnson urges the next Administration to continue to focus on - in addition to our vital missions - improving the manner in which the Department conducts business. This is essential to support our people on the front lines and the public we are all committed to protecting. (The White House, 1/5/17)

REPORT
Climate Change: Improved Federal Coordination Could Facilitate Use of Forward-Looking Climate Information in Design Standards, Building Codes, and Certifications. Continuing to build with current standards and codes could cost the government billions of dollars in repairs, flood insurance, and disaster relief. GAO recommends that federal agencies work together to provide forward-looking climate information for consideration in standards and codes. (GAO, 1/3/17)

REPORT
Vermont Utility Cybersecurity Alarm. Although the Vermont incident proved not to be as serious a cybersecurity threat as initially reported, there are legitimate concerns with attempts by hackers and others to infiltrate the US electric grid, especially in the wake of the cyberattack on the electric grid in Ukraine in late December 2015. (Congressional Research Service 1/3/17)

EXECUTIVE ORDER
Taking Additional Steps to Address the National Emergency with Respect to Significant Malicious Cyber-Enabled Activities. President Obama, in order to take additional steps to deal with the national emergency with respect to significant malicious cyber-enabled activities declared in Executive Order 13694 of April 1, 2015. (The White House, 12/29/16)

See also:

BLOG
Science and Technology in Service of National Disaster Preparedness, Reduction, and Resilience. Today, the White House Office of Science and Technology Policy (OSTP) and the National Science and Technology Council's (NSTC) Committee on Environment, Natural Resources, and Sustainability and Committee on Homeland and National Security are pleased to release a report, a plan, and a review that will improve the Nation's preparedness for and resilience to potential disasters, whether natural or manmade. (The White House, 12/20/16)

Radiological & Nuclear Disaster Preparedness

BLOG
NNSA and Interagency Partners Conduct Radiological Counterterrorism Tabletop Exercise. NNSA, in partnership with the Federal Bureau of Investigation's Weapons of Mass Destruction Directorate, recently conducted the "Atomic Thunder" tabletop exercise at the Rhode Island Nuclear Science Center in Narragansett. Emergency responders from Narragansett and the surrounding area participated. (NNSA, 1/4/17)

Science & Technology Policy

GUIDANCE
Principles for Promoting Access to Federal Government-Supported Scientific Data and Research Findings Through International Scientific Cooperation. These principles apply to unclassified scientific data generated by Federal agencies or resulting from Federally funded research ("government-supported scientific data"), which can include primary data (e.g., observations and measurements) and derived data (resulting from computations performed on the primary data), together with accompanying metadata that exist in digital form, as well as publications that result from Federally funded scientific research. (The White House, 1/6/17)

See also: Strengthening Global Sharing of Scientific Data and Research Findings (The White House, 1/6/17)

PRESS RELEASE
Federal Budget Authority for Research and Development Continues Upward Trend. Federal budget authority for research and development (R&D) rose in Fiscal Year (FY) 2016, the third straight year of current dollar increases, according to a new report from the National Center for Science and Engineering Statistics. (National Science Foundation, 1/5/17)

MEMORANDUM
Exit Memo: Office of Science and Technology Policy. In this memorandum, Dr. John P. Holdren & Megan Smith: (1) highlight the profound impact President Obama's leadership has had in "reaffirming and strengthening America's role as the world's engine of scientific discovery and technological innovation,"[2] as he set out to do at the start of his Administration; (2) offer an overview of frontiers that the American S&T enterprise will advance in the coming decades; and (3) call for actions needed in the years ahead to include all Americans in driving continued innovation and progress across those frontiers. (The White House, 1/5/16)

REPORT
Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. This Update to the Coordinated Framework is a sequel to the 1986 Coordinated Framework for the Regulation of Biotechnology (the 1986 Coordinated Framework) and the 1992 Update to the Coordinated Framework and is intended to clarify the current roles and responsibilities of the primary agencies involved in the regulation of biotechnology products. (The White House, 1/17)

INTERVIEW
Keeping Biosecurity in the Forefront: A Conversation with Renee Wegrzyn. This year's annual SynBioBeta SF 2016 conference featured a lively panel discussion on how stakeholders in the synthetic biology industry can go about safeguarding the bioeconomy. Panelists from the FBI, DARPA, academia, and industry all weighed in on this topic that is both fascinating and timely for the field of synthetic biology. Here we will continue the conversation through an extended interview with one of the distinguished panelists: DARPA program manager Renee Wegrzyn. (Synbiobeta, 12/28/16)

NEWS
National Biotechnology Panel Faces New Conflict of Interest Questions. The National Academies of Sciences, Engineering and Medicine are assigned by Congress to provide policy guidance to the government. The group describes itself as "advisers to the nation." One of its committees is facing questions about how its members were selected. The concerns focus on a panel studying biotechnology , a booming area of business, including in the food industry, and one of the most contentious scientific issues in Washington . (New York Times, 12/27/16)

PERSPECTIVE
The 21st Century Cures Act - A View from the NIH. Drs. Kathy L. Hudson and Francis S. Collins focus on aspects of the Cures Act that are directly relevant to the NIH's mission - measures that will provide the agency with critical tools and resources to advance biomedical research across the spectrum from basic, curiosity-driven studies to advanced clinical trials of promising new therapies. (New England Journal of Medicine, 12/13/16)

This Week's Hearings

There are no hearings scheduled for this week.