July 12, 2016
Gigi Kwik Gronvall, Matthew P. Shearer, and Hannah Collins

This document summarizes the governmental policies and regulations for biosafety in research laboratories in the nations of Brazil, China, India, Israel, Pakistan, Kenya, Russia, Singapore, the United Kingdom, and the United States. Previous research suggests a lack of international norms governing biosafety precautions for dangerous or especially contagious pathogens; by describing a variety of biosafety governance approaches in these nations, the project team discovered areas of commonality which could be further developed into international norms.



Public Health & Healthcare Preparedness
COMMENTARY
United States Health Care Reform: Progress to Date and Next Steps.
 
President Barack Obama explains why policy makers should build on progress made by the Affordable Care Act by continuing to implement the Health Insurance Marketplaces and delivery system reform, increasing federal financial assistance for Marketplace enrollees, introducing a public plan option in areas lacking individual market competition, and taking actions to reduce prescription drug costs. Although partisanship and special interest opposition remain, experience with the Affordable Care Act demonstrates that positive change is achievable on some of the nation's most complex challenges.  (JAMA, 7/11/16)

NEWS
Congress Will Fight Over Guns, Zika as it Sprints for Recess.
 
With just one week left before they leave for a nearly two-month summer break, lawmakers will renew their fights over gun control and Zika money - as Congress sprints to get out of town ahead of the political conventions and the height of campaign season. (Politico, 7/10/16)

See also:
REPORT
Overview, Control Strategies, and Lessons Learned in the CDC Response to the 2014-2016 Ebola Epidemic.
 
Lessons learned include the recognition that West African and other countries need effective systems to detect and stop infectious disease threats, the need for stronger international surge capacity for times when countries are overwhelmed by an outbreak, and the importance of improving infection prevention and control in health care settings. (CDC, 7/8/16)


EMERGENCY USE AUTHORIZATION
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, 7/8/16)
 
FUNDING OPPORTUNITY
Protecting and Improving Public Health Globally: Building and Strengthening Public Health Impact, Systems, Department of Health and Human Services.
 
The US Government's Global Health Security Agenda envisions a world safe and secure from global health threats posed by infectious diseases -- where it is possible to prevent or mitigate the impact of naturally occurring outbreaks and intentional or accidental releases of dangerous pathogens, rapidly detect and transparently report outbreaks when they occur, and employ an interconnected global network that can respond effectively to limit the spread of infectious disease outbreaks in humans and animals, mitigate human suffering and the loss of human life, and reduce economic impact. (Grants.gov, 7/8/16)
 
REPORT
Drug Shortages: Certain Factors are Strongly Associated with this Persistent Public Health Challenge.
 
This report examines (1) trends in drug shortages, (2) FDA's efforts to prioritize reviews of drug submissions to address shortages, (3) trends in FDA warning letters issued to sterile injectable manufacturing establishments for noncompliance with manufacturing standards, and (4) the relationship between certain factors and shortages of sterile injectable drugs. (GAO, 7/7/16)
 
BLOG
IHS Issues New Policy Ensuring Modern, Functional Medical Equipment.
 
Expanding efforts to ensure medical equipment used at Indian Health Service (IHS) facilities is up to date, properly maintained, and reliable, IHS has established a new policy which standardizes and clarifies the minimum standards for medical equipment management, purchase, maintenance, and replacement. (Indian Health Service, 7/7/16)
 
NEWS
US Army Partners with Sanofi Pasteur to Develop Zika Vaccine.
 Walter Reed Army Institute of Research (WRAIR) 
scientists and collaborators are moving rapidly to develop and test the Zika Purified Inactivated Virus (ZPIV) vaccine candidate because it builds on "a flavivirus vaccine platform WRAIR previously developed which has been proven to be safe, effective, and able to meet regulatory requirements of the US FDA," said Col. Stephen Thomas, an Army infectious diseases physician, vaccinologist, and the WRAIR Zika program lead. (Global Biodefense, 7/6/16)
 
STATEMENT
US Centers for Disease Control and Prevention and Environmental Protection Agency Urge Commonwealth of Puerto Rico to Consider Aerial Spraying as Part of Integrated Mosquito Control to Reduce Zika-Associated Birth Defects.
 
"Multiple independent data sources indicate that at current trends thousands of pregnant women in Puerto Rico will catch Zika," said CDC Director Tom Frieden, M.D., M.P.H. "The continental United States has been using aerial spraying for decades to reduce mosquito populations, and we urge the people of Puerto Rico to consider using the same proven and safe tactic." (CDC, 7/6/16)
 
PRESS RELEASE
Appropriations Committee Releases the Fiscal Year 2017 Labor, Health and Human Services Funding Bill.
 
The legislation includes a total of $7.8 billion for CDC - $605 million above the fiscal year 2016 enacted level and $800 million above the President's budget request. The bill also provides $300 million to create a new Infectious Diseases Rapid Response Reserve Fund, which will give the CDC Director immediate access to funds to respond to any future infectious disease emergency such as Ebola or Zika. (US House Committee on Appropriations, 7/6/16)

See also
BLOG
Global Health Security: How is the US Doing?
 A Joint External Evaluation Team 
specifically recognized the challenges any federal public health system faces, and advised the US to continue improving the understanding of the International Health Regulations among different federal and state agencies. Their observations will help drive improvements for programs throughout CDC and the nation. The US requested this unbiased review of its response capabilities and hopes that the entire world will do the same. (CDC, 7/5/16)
 
BLOG
Zika Vaccine: Two Candidates Show Promise in Mice.
 
This fall, NIAID and Walter Reed plan to launch two clinical trials of inactivated viral vaccines. The trials, each involving dozens of volunteers, will test to see whether the vaccines are safe and elicit an immune response in people. (NIH, 7/5/16)
 
NEWS
FDA: Marketing, Labeling of Animal Antibiotics to Change in 2017.
 
The US Food and Drug Administration is tightening up regulations on the marketing and labeling of so-called "medically important antimicrobials" used on food animals. Such a move has long been sought by those concerned about how overuse of such drugs can lead to antibiotic resistance and threaten public health. (Food Safety News, 7/5/16)
 
NEWS
Army Metes Out Punishment in Anthrax Scandal.
 
The Army has disciplined 10 of 12 civilian and military personnel deemed responsible for the poor laboratory practices and the "culture of complacency" that led to the bungled shipments of deadly anthrax samples to 50 states and nine foreign countries. (USA TODAY, 7/5/16)
 
PRESS RELEASE
During Obama Administration, USDA Has Made Most Significant Food Safety Updates Since 1950s.
 
Over the past seven years, the US Department of Agriculture's Food Safety and Inspection Service has instituted some of the most significant updates to our country's food safety system since the 1950s, leading to a 12 percent drop in foodborne illness associated with meat, poultry and processed egg products from 2009 to 2015. (USDA, 7/5/16)

See also:
PRESS RELEASE
PREVAIL Treatment Trial for Men with Persistent Ebola Viral RNA in Semen Opens in Liberia.
 
The six-month study will enroll 60 to 120 EVD survivors whose semen has evidence of Ebola virus RNA prior to their enrollment. Participants in the double-blind trial will receive either investigational drug GS-5734, manufactured by Gilead Sciences, Inc., or a placebo. (NIAID, 7/5/16) (NIAID, 7/5/16)
 
FUNDING OPPORTUNITY
To Strengthen Collaboration between CDC and the National TB Controllers and the National TB Nurse Coalition Project.
 Funds are available to one recipient to work in collaboration with the CDC/Tuberculosis Elimination to strengthen collaborations between CDC and the National Tuberculosis (TB) Controllers that will lead to the control and ultimate elimination of tuberculosis in the United States
(Grants.gov, 7/1/16)

WEBINAR
HHS Summit to Accelerate Zika Diagnostics Development.
 
The objectives of the Summit are to accelerate development of Zika Diagnostics for FDA EUA or clearance; facilitate developer access to clinical samples; identify solutions to improve Zika diagnostic assay sensitivity and specificity; and allow assay developers and reagent creators the opportunity to form collaborations for better Zika diagnostics. The Summit will be held July 15, 8:30 AM - 5 PM EST. In-person registration for the Summit has been closed; additional attendees may participate via web conference. (MedicalCountermeasures.gov, 7/16)

 

CONFERENCE
Superbugs & Superdrugs USA: The Global Attack Against Bacteria's Defensive Walls.
 
This conference will provide a timely platform for both pharmaceutical and healthcare experts to share their research updates and insights in this subject -- driving the rebuild of a global defensive wall of bacteria. Speakers include Christopher Houchens (Branch Chief, Antibacterials Program, BARDA) and Rosemarie Aurigemma (Chief, Biodefense Drug Development Section, NIH). The conference will take place November 14-15, 2016. Registration is required. (SMi, 7/16)
 
CALL FOR APPLICATIONS
Uniquely Skilled Senior Anti-Microbial Resistance Technical Advisor (AMR USSTA).
 
The AMR USSTA will serve in USAID's Global Health Fellows Program, where s/he will aim to increase the quality of the technical and strategic capacity across USAID's entire Infectious Diseases portfolio including TB, Malaria, NTDs, HIV, and other relevant disease areas. S/he will also coordinate across the disease areas within USAID and across the United States Government agencies. Application period open until 8/31/16. (USAID, 7/16)
 
FELLOWSHIP
Public Health Fellowship in Government.
 
The Fellowship in Government provides a unique public policy learning experience, demonstrates the value of science-government interaction and enhances public health science and practical knowledge in government. APHA is looking for candidates with strong public health credentials and an interest in serving as a staff person in the US Congress. Applications due by midnight EST on August 15, 2016. (APHA, 7/16)
 

Homeland Security & Disaster Preparedness
NEWS
ECBC Develops Chemical Agent Decontamination Spray for Active Soldiers in the Field.
 
The spray was developed by ECBC's Chemical, Biological, Radiological (CBR) Filtration Branch. The spray itself is based on zirconium hydroxide as a filtration absorbent that was also discovered to react with and neutralize chemical agent molecules. (Homeland Preparedness News, 7/11/16)
 
NEWS
US Chemical Safety Board Investigates Mississippi Natural Gas Plant Accident.
 
The US Chemical Safety Board launched its first major investigation in a year with a probe of a June 27 fire and explosion at a natural gas processing facility in Pascagoula, Miss. The accident occurred in one of three process lines, or trains, as the facility handles incoming hydrocarbons and separates the material into natural gas liquids and residual gas.  (Chemical & Engineering News, 7/11/16)
 
NEWS
The Weird Science of Forecasting Global Crisis.
 
The CIA pays political scientists to predict instability -- and they're usually right. In 1994, the CIA's Directorate of Intelligence commissioned the Political Instability Task Force, formerly known as the State Failure Task Force, a clairvoyant-esque squad of social-scientist brainiacs charged with churning global political data into global instability forecasts. (War is Boring, 7/10/16)
 
NEWS
US Experienced at Least 8 Billion-Dollar Disasters So Far This Year.
 
We're only halfway through 2016 and the US has already seen eight weather and climate-related disasters that have each met or exceeded $1 billion in damages. These eight disasters resulted in the loss of 30 lives, and caused at least $13.1 billion, according to an analysis by NOAA's National Centers for Environmental Information. (NOAA, 7/7/16)
 
PRESS RELEASE
The Department of Homeland Security Announces the Countering Violent Extremism Grant Program.
 
On Wednesday, July 6, 2016, Secretary of Homeland Security Jeh Johnson announced the Fiscal Year (FY) 2016 Countering Violent Extremism (CVE) Grant Program, with $10 million in available funds. This is the first federal assistance program devoted exclusively to providing local communities with the resources to counter violent extremism in the homeland. (Department of Homeland Security, 7/6/16)
 

Radiological & Nuclear Disaster Preparedness
NEWS
Obama Plans Major Nuclear Policy Changes in His Final Months.
 
The administration also wants to cut back long-term plans for modernizing the nation's nuclear arsenal, which the Congressional Budget Office reports will cost about $350 billion over the next decade. Obama may establish a blue-ribbon panel of experts to examine the long-term budget for these efforts and find ways to scale it back. (Washington Post, 7/10/16)
 
NEWS
NRC Doubles Maximum Fine.
 
On July 1, the Nuclear Regulatory Commission announced that, following changes in federal law, it has revised its regulations to increase the potential maximum civil penalty for violations of the Atomic Energy Act from $140,000 to $280,000. (Occupational Health & Safety, 7/5/16)
 
PRESS RELEASE
REAC/TS Celebrates 40 Years as International Leader in Emergency Medical Response.
 
REAC/TS supports the Department of Energy's National Nuclear Security Administration to strengthen medical response to radiation emergencies; during the past 40 years, REAC/TS staff have been on call 24 hours a day, seven days a week to provide direct medical care or consultation involving radiation exposure across the globe. (NNSA, 7/1/16)
 

Science & Technology Policy
NEWS
Theranos Founder Elizabeth Holmes Barred from Operating Labs for Two Years.
 
Centers for Medicare & Medicaid Services, a federal regulator, said in a letter made public Friday that it is also revoking certification for the company's Newark, California laboratory and cancelling the lab's approval to receive Medicare payments. (NPR, 7/9/16)

COMMENTARY
Policy Implications of Aging in the NIH-Funded Workforce.
 
This analysis, conducted by researchers at the US Census Bureau, the National Science Foundation, NIH, and the Foundation for Food and Agricultural Research, suggests that the collective aging of the NIH-funded independent investigator workforce is not solely the product of any policy or mechanism. Rather, it is an accumulation of multiple factors including a shift in perceptions, expectations, and the general structure of the extramural workforce, as well as global macroeconomic factors. (Cell, 7/7/16)
 
NEWS
Obama's Top Scientist Talks Shrinking Budgets, Donald Trump, and His Biggest Regret.
 
John Holdren is no stranger to the spotlight. Over his long career in science, Holdren - a physicist by training - has worked on controversial issues such as climate change and nuclear non-proliferation. (Nature, 7/6/16)
 
BLOG
Take Precautions to Avoid Zika Virus Infection During Trips Abroad.
 I
f you are traveling abroad, first check the Centers for Disease Control and Prevention's travel page to see if Zika is spreading in your planned destination. Zika virus is currently being spread in Mexico, Central and South America, the Caribbean, the Pacific Islands, and parts of Africa. (ASPR, 7/6/16)
 
NEWS
House Panel Set to Endorse $1.3 Billion Increase for the NIH.
 
The House bill would increase spending for Alzheimer's research by $350 million and provide a $45 million increase for the BRAIN Initiative, the Obama administration's program to map the human brain. It also authorizes the full $300 million that the White House requested for its precision medicine initiative. (STAT News, 7/6/16)
 
PRESS RELEASE
NIH Awards $55 Million to Build Million-Person Precision Medicine Study.
 
The knowledge gained from the PMI Cohort Program will extend successes of precision medicine in some cancers to many other diseases.  Importantly, the program will focus not just on disease, but also on ways to increase an individual's chances of remaining healthy throughout life. (NIH, 7/6/16)

GUIDANCE
User Guide for Medical Educators.
 
The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) has developed educational materials for use in traditional and nontraditional educational settings to provide educators with contemporary examples of real-life ethical challenges addressed by a presidential commission. The purpose of this guide is to highlight the most relevant materials for educators in medicine and the health sciences. (Bioethics.gov, 7/5/16)
 
This Week's Hearings
Strengthening our National Trauma System. US House Committee on Energy & Commerce, Subcommittee on Health. 7/12/16, 10 AM, Rayburn 2322. More

Oversight of CERCLA Implementation. US House Committee on Energy & Commerce, Subcommittee on Environment and the Economy. 7/13/16, 10 AM, Rayburn 2123. More

Disrupter Series: Health Care Apps. US House Committee on Energy & Commerce, Subcommittee on Commerce, Manufacturing, and Trade. 7/13/16, 10:15 AM, Rayburn 2322. More

Zika in the Western Hemisphere: Risks and Response. US Senate Committee on Foreign Relations, Subcommittee on Western Hemisphere, Transnational Crime, Civilian Security, Democracy, Human Rights, and Global Women's Issues. mm/dd/yyyy, time (am/pm), Building name, room no. More


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