e-Public Policy Update - October

Contents:

  • ASM Alerts Members to USG Deliberative Process on Gain-Of-Function Research
  • USG Releases Final US Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
  • Members Alerted to USG Biosafety Communications
  • ASM Testifies Before the Federal Experts Security Advisory Panel on Issues Related to Biosafety and Biosecurity
  • ASM Meetings with Policy Makers
  • ASM Statement on National Strategy to Combat Antibiotic Resistant Bacteria
  • PSAB Response to Ebola Virus Outbreak
  • ASM Joins CDC COCA Emergency Preparedness and Response Call
  • ASM Staff Attends the Johns Hopkins University Ebola Forum
  • ASM Committee Updates Interim Ebola Guideline
  • ASM Submits Comments on the NIGMS Strategic Plan
  • ASM Attends CCCLW Organizational Meeting
  • Continuing Resolution to Extend Federal Research Funding
  • NSF BIO Assistant Director Named
  • ASM Attends CPT Pathology Coding Caucus Meeting
  • ASM Staff Attend House Committee Hearing on LDTs
  • ASM Sends CMS Comments on CME and Local Coverage Determination
  • ASM Comments on Rapid Influenza Test Classification
  • Statement on America COMPETES Act Reauthorization
  • Minority Microbiology Mentor Newsletter

ASM Alerts Members to USG Deliberative Process on Gain-Of-Function Research
ASM’s Public and Scientific Affairs Board (PSAB) sent an alert to members on the White House Office of Science and Technology Policy announcement that the US government will undertake a deliberative process to assess the risks and benefits of certain gain-of-function (GOF) experiments with influenza, SARS, and MERS viruses in order to develop a new Federal policy regarding the funding of this research. The ASM has previously commented on the process of assessing the risks of such GOF research and supported consideration by the National Academy of Sciences. The ASM will to participate in the discussions of the National Science Advisory Board on Biosecurity and the National Academy of Sciences and notes that several members of the Public and Scientific Affairs Board and former ASM Presidents are directly involved in these forums. ASM will also continue to work with the USG to ensure the safe conduct of microbiological research. For more information go to ASM’s Biosafety/Biosecurity web page at: http://www.asm.org/ASM-biosafety-biosecurity.

ASM Alert on USG Releases Final US Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
The PSAB sent members a notice concerning the United States Government’s final Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). The policy articulates the responsibilities of institutions and investigators to identify and manage any risks associated with DURC. DURC is life sciences research that based on current understanding can be reasonably anticipated to provide knowledge, information, products or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The policy addresses Institutional oversight of DURC which is considered the critical component of a comprehensive oversight system. The policy covers 15 select agents and toxins and seven experiments of concern and requires institutions to certify compliance as of one year from the announcement date. The ASM submitted comments on the draft policy in April 2013. To see the compiled resources on DURC policies, go to https://www.asm.org/index.php/public-policy/98-policy/issues/93178-durc-9-14.

Members Alerted to USG Biosafety Communications
The PSAB notified members of several federal government communications on biosafety following the biosafety incidents earlier this year at the CDC and NIH. On August 19, the White House Office of Science and Technology Policy (OSTP) posted the Memorandum entitled “Ensuring Biosafety and Biosecurity in US Laboratories.” The OSTP and the National Security Council sent the Memo to federal agencies involved in life sciences research urging them to take immediate and longer term steps aimed at addressing the underlying causes of recent laboratory incidents and strengthening biosafety and biosecurity at federal facilities. In an explanatory statement, the OSTP said it also encouraged extramural facilities that receive federal funding to review biosafety and biosecurity best practices and protocols and implement plans for sustained inventory monitoring. The Memo outlines processes for federal and nonfederal committees to review and make recommendations to strengthen biosafety and biosecurity for federally funded activities. The Memorandum and explanatory background are posted at http://www.whitehouse.gov/blog/2014/08/28/ensuring-biosafety-and-biosecurity-us-laboratories.  The PSAB sent an alert to members regarding the memo which included the NIH Notice instituting a National Biosafety Stewardship month in September for NIH and DHHS agencies, and urging NIH grantee institutions to do the same at the local level. The alert with the details of the NIH’s Stewardship month is posted on the Public Policy Biosafety page: http://www.asm.org/index.php/public-policy/98-policy/issues/93097-usg-bio-9-14.    The page also includes earlier alerts from the PSAB on biosafety lapses, dual use research of concern and the reminder alert for ASM members to practice safe “laboratory housekeeping.”

ASM Testifies Before the Federal Experts Security Advisory Panel on Issues Related to Biosafety and Biosecurity
On October 27, Ronald Atlas, Ph.D., Chair of the Public and Scientific Affairs Board testified before the Federal Experts Security Advisory Panel. To strengthen US Government oversight for work with infectious agents, including (but not limited to) Biological Select Agents and Toxins (BSAT), the FESAP has undertaken a comprehensive federal review that will result in specific recommendations to strengthen the government's biosafety and biosecurity practices and oversight system for federally-funded activities, consistent with the need to realize the public health and security benefits of such work. The ASM will address the following tasks in its testimony: 1. Identify needs and gaps and make recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for BSAT, 2. Identify actions and any regulatory changes necessary to improve biosafety and biosecurity., 3. Identify an approach to determine the appropriate number of high  containment U.S. laboratories required to possess, use, or transfer BSAT. The ASM’s presentation is posted at: http://www.asm.org/images/PSAB/ASM-FESAP-Presentation-Oct-2014.pdf.

ASM Meetings with Policy Makers
On October 22, Ronald Atlas, Chair of the PSAB, Timothy Donohue, President of ASM and Janet Shoemaker met with officials at the Office of Science and Technology Policy about Ebola issues and Gain-of-Function policy.

On October 24, Dr. Atlas, Kenneth I. Berns, Chair, PSAB Committee on Biodefense and Gail Cassell, Chair of the PSAB Committee on Biomedical Research and Janet Shoemaker went to Ft. Detrick to meet with officials from the US Army Medical Research and Materiel Command to discuss medical microbiology activities at USAMRID.

On October 21, Kimberly Walker, Ph.D., Manager, Public Affairs, attended a meeting at the White House with Sarah Charles, NSC Director for Development and Humanitarian Affairs and Nancy Abella, NSC Director for Immigration and Visa Security to discuss the Administration’s efforts to combat and treat Ebola in West Africa, and on developments in connection with the domestic response. Dr. Walker participated in a conference call on October 16 with Nancy Lindborg, Assistant Administrator, United States Agency for International Development, Nancy Abella, Director for Immigration and Visa Security, National Security Council, Sarah Charles, Director for Development and Humanitarian Affairs, National Security Council and Officials from the State Department’s Ebola Coordination Unit and the Centers for Disease Control and Prevention to hear about the U.S. Response to the Ebola Crisis. On October 24 Dr. Walker also participated in a conference call with Dr. Jo Handelsman, Assistant Director for Science, Office of Science and Technology Policy Beth P. Bell, MD, MPH, Director, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Arjun Srinivasan, MD (CAPT, USPHS), Associate Director for Healthcare Associated Infection Prevention Programs, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention and Wendy Taylor, Director, Center for Accelerating Innovation and Impact, U.S. Agency for International Development to discuss steps the Administration is taking in response to the Ebola crisis and the scientific community’s role in response efforts.

ASM Statement on National Strategy to Combat Antibiotic Resistant Bacteria
The ASM sent a statement on the National Strategy to Combat Antibiotic Resistant Bacteria (CARB), which was announced by President Obama on September 18, to ASM members, Congress and other policy makers. The strategy outlines a number of steps to slow the public health threat of antibiotic resistant bacteria, including efforts to stimulate innovative research.   Importantly, the Strategy will establish a new Task Force for Combatting Antibiotic Resistant Bacteria which is directed to submit an action plan to the President by February 2015. This elevated attention at the highest level of government is needed because in the United States alone, antibiotic resistant bacteria cause 2 million infections a year and 23,000 deaths. To read the statement with links to the CARB Strategy and Executive Order go to: http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93168-ar-2014.

On October 27, the ASM sent a letter to the Office of Management and Budget regarding funding the National Strategy to Combat Antibiotic Resistant Bacteria (CARB) and the recommendations of the President’s Council of Advisors on Science and Technology (PCAST) to combat antibiotic resistance. The letter was signed by 53 organizations and is available at: https://www.asm.org/images/PSAB/OMB-CARBFunding.pdf.

PSAB Responses to Ebola Virus Outbreak
In light of the Ebola Virus outbreak in Western Africa and several cases in the US, the PSAB has set up a web page which includes a compendium of resources, including ASM statements and interim guidance for laboratory personnel handling specimens that may contain Ebola virus, journal articles and information from the responsible federal agencies. On October 2, the PSAB sent out a statement to ASM clinical members updating them on CDC interim guidance documents for specimens and the enhanced guidance document from the Laboratory Practices Committee. On September 23, the PSAB sent letters to Sylvia M. Burwell, Secretary US Department of Health & Human Services and David Nabarro, M.D., Senior United Nations System Coordinator for Ebola Virus Disease with recommendations concerning molecular monitoring of the evolving viral strain and the need for scientific resources. To read all of the ASM policy statements and letters regarding the Ebola outbreak go to: http://www.asm.org/index.php/news-room/asm-press-releases/89-news-room/media-info/93111-asm-ebola-resources.

On October 28, PSAB sent an alert to members regarding the White House Office of Science and Technology Policy (CDC) challenge to develop Ebola tools. This program solicits the global community to share innovative ideas that deliver practical and cost-effective innovations to address this crisis, to improve delivery of care, and stem the spread of Ebola virus disease. The alert is available at: http://www.asm.org/index.php/news-room/asm-press-releases/137-policy/documents/statements-and-testimony/93231-ebola-10-28-14.  

On October 29, PSAB issued a statement on the CDC’s new Interim Guidance on Monitoring and Movement of Persons with Suspected Ebola Contact. While quarantine is primarily a state by state responsibility, there is a need for a coherent national policy. CDC has quarantine authority for interstate movement of persons who pose a public health risk; states have authority within their own borders. The CDC guidelines are based on current scientific and medical evidence that Ebola is transmitted only by direct contact with body fluids from someone who is symptomatic i.e., onset of fever, fatigue, muscle pain, headache, sore throat, followed by vomiting, diarrhea, rash and, in some cases, both internal and external bleeding. The guidelines provide additional layers of protection against the inadvertent spread of Ebola within the United States since isolation and restricted travel of asymptomatic individuals with suspected high risk Ebola contact provides adequate public health protection. The statement is available at: http://www.asm.org/index.php/news-room/asm-press-releases/93-policy/93236-ebola-10-29-14.

ASM Committee Updates Interim Ebola Guideline
On September 10, the PSAB Committee on Laboratory Practices updated their “Interim Laboratory Guidelines for Handling/Testing Specimens from Cases or Suspected Cases of Hemorrhagic Fever Virus (HFV)” after consultation with Centers for Disease Control and Prevention (CDC) personnel. The guidelines are intended to assist clinical laboratory staff in following the CDC’s “Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with Suspected Infection with Ebola Virus Disease”, posted August 5. To see ASM’s guidelines, go to   http://www.asm.org/images/PSAB/Ebola9-10-14.pdf.  

ASM Joins CDC COCA Emergency Preparedness and Response Call
On October 14, ASM staff joined the Centers for Disease Control and Prevention (CDC) in their Clinician Outreach and Communication Activity (COCA) call entitled “Preparing for Ebola: What U.S. Hospitals Can Learn from Emory Healthcare and Nebraska Medical Center.” The focus of this activity was to discuss overall healthcare systems preparedness, although several references to specific laboratory procedures were mentioned. COCA provides timely, accurate, and credible information to clinicians related to emergency preparedness and response and emerging public health threats. To see the materials related to the call, please go to http://emergency.cdc.gov/coca/calls/2014/callinfo_101414.asp.

ASM Staff Attends the Johns Hopkins University Ebola Forum
The Johns Hopkins Bloomberg School of Public Health hosted a “Dean’s Symposium on Ebola: Crisis, Context and Response” on October 14. Speakers discussed the impact of the epidemic, current and proposed future responses, the current status of vaccines and therapeutics, and recommendations to prevent spread of the disease outside West Africa. To see the agenda and view the archived webcast, go to the following page http://www.jhsph.edu/events/2014/ebola-forum/.  

ASM Submits Comments on the NIGMS Strategic Plan
The ASM, with input from the PSAB committees on Microbiological Issues Impacting Minorities and Biomedical Research, provided comments in a letter to the National Institute of General Medical Sciences on its 2015 Strategic Plan. The comments encouraged the NIGMS to support training programs to support the development of a diverse and highly trained workforce, emphasized the importance of investigator-initiated research and urged NIGMS to take the lead in cross-institute initiatives.   ASM’s President Timothy Donohue, Ph.D., participated in the NIGMS Strategic Planning Meeting which solicited input from concerned stakeholders. The ASM also alerted members to the opportunity to send comments to NIGMS on the plan. ASM comments are available at: http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93180-nigms-sp-9-14.

ASM Attends CCCLW Organizational Meeting
ASM Staff attended the September 14 Coordinating Council on the Clinical Laboratory Workforce (CCCLW) meeting in Chicago. Although the mission of the Council has not changed, the focus for the next year will be to increase healthcare and public awareness of laboratory professionals in achieving positive patient outcomes. As always, CCCLW will seek to increase the number of qualified clinical laboratory professionals and to enhance the image of clinical laboratory professionals. Follow http://www.ccclw.org/default.html for details on upcoming projects.

Continuing Resolution to Extend Federal Research Funding
On September 9, the House Appropriations Committee Chairman, Representative Hal Rogers (KY-5), introduced a short term $1.012 trillion Continuing Resolution (CR) that would fund the federal government until December 11, 2014 and prevent a government shutdown. The legislation remains within current spending caps and provides new funding for Ebola research and response. Congress is expected to vote on the measure before the end of the current fiscal year (FY) in September. A copy of the bill can be found: http://rules.house.gov/bill/113/hj-res-124 and for up to date budget and appropriations information please visit the ASM Public Policy webpage at: http://www.asm.org/ResearchFunding.

NSF BIO Assistant Director Named
In September, the National Science Foundation (NSF) announced the selection of James L. Olds as the new Assistant Director for the Directorate for Biological Sciences (BIO.) In the NSF press release, Jo Handelsman, Associate Director for Science at the White House Office of Science & Technology Policy (OSTP) and Past ASM President said: "Dr. Olds' commitment to the pursuit of rigorous scientific research that can help solve society's grandest challenges makes him supremely qualified to lead the NSF's Biological Sciences Directorate." The PSAB is scheduled to meet with the new BIO Director on December 11. The press release can be found on the NSF website at: http://www.nsf.gov/news/news_summ.jsp?cntn_id=132477&org=NSF&from=news

ASM Attends CPT Pathology Coding Caucus Meeting
PSAB Professional Affairs Committee Chair Robert Jerris attended the September 12 meeting of the Pathology Coding Caucus (PCC). The PCC makes coding recommendations on new clinical laboratory tests to the American Medical Association (AMA), which is responsible for official Current Procedural Terminology (CPT®) coding, the most widely accepted medical nomenclature used to report medical procedures and services under private and public health insurance programs, including Medicare. ASM is a rotating member of the PCC.

ASM Staff Attend House Committee Hearing on LDTs
On September 9, The House Energy and Commerce Subcommittee on Health held a hearing on Laboratory Developed Tests (LDTs), which ASM staff attended. The hearing was intended to provide the Subcommittee with a better understanding of how LDTs are performed in clinical practice, what their impact has been on personalized medicine, and how innovation can be fostered in clinical tests. It also provided an opportunity to hear from the Food and Drug Administration (FDA) and a variety of stakeholders about the Agency’s recently proposed regulatory framework for the review and oversight of such tests. To watch the archived hearing, go to http://energycommerce.house.gov/hearing/21st-century-cures-examining-regulation-laboratory-developed-tests.  

ASM Sends CMS Comments on CME and Local Coverage Determination
On September 2, ASM sent comments on the “Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015” as published in the July 11 Federal Register. The comments focused on two proposed changes: the funding of continuing medical education (CME) and the local coverage determination (LCD) process for laboratory testing.   To see the comments, click the link http://www.asm.org/index.php/documents/statements-and-testimony/137-policy/documents/statements-and-testimony/93126-cme-9-14.  

ASM Comments on Rapid Influenza Test Classification
In August, the Committee on Laboratory Practices sent comments to the FDA on their proposal to reclassify rapid influenza virus antigen detection tests. The rapid emergence of novel or variant influenza strains requires stringent oversight of rapid influenza direct tests (RIDTs) to ensure their accuracy and safety. Therefore, the ASM fully supports the FDA’s proposal and the FDA’s Microbiology Advisory Panel recommendation that all RIDTs currently regulated be reclassified into class II with special controls under the new device name “influenza virus antigen detection test system.” To read the comments in full, please see http://www.asm.org/index.php/component/content/article/137-policy/documents/statements-and-testimony/93035-fda-8-20.

Statement on America COMPETES Act Reauthorization
In September, the ASM, as a member of the Coalition for National Science Funding (CNSF), signed a coalition letter thanking the Senate Commerce, Science and Transportation Committee for introducing a reauthorization bill for the America COMPETES Act that would grow the NSF’s budget over five years. The letter stated that: “A predictable pattern of funding will facilitate a continuous stream of high level research and researchers that, in turn, will support the level of technological development needed for economic growth.” For more information on the COMPETES Act and other legislation relevant to microbiology and the ASM membership, visit the Public Policy webpage at: http://www.asm.org/policy.

Minority Microbiology Mentor Newsletter
The October issue of the Minority Microbiology Mentor Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities. To read the newsletter, go to: https://www.asm.org/index.php/publicpolicy-2/newsletters/minority-microbiology-newsletter/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93205-mmm-10-14.

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