e-Public Policy Update – October 2016

Contents:

  • ASM President Attends UN Meeting on Combating Antimicrobial Resistance
  • Congress Passes Continuing Resolution and Funds Zika Response
  • ASM Authors Document on mcr-1 Colistin Resistance
  • ASM Participates in FDA Public Workshop on Antimicrobial Issues
  • ASM Congressional Science Fellow Secures Congressional Office Position
  • Minority Microbiology Mentor Newsletter
  • October is National Biosafety Month
  • House Energy and Commerce Subcommittee Holds Hearing on Dangerous Pathogens
  • The Centers for Disease Control and Prevention Will Fund 34 Innovative Projects to Combat Antibiotic Resistance
  • The Food and Drug Administration (FDA) Released Draft Guidance for the Development of Antimicrobials and Antimicrobial Susceptibility Tests
  • GAO Releases Report on NIH Indirect Costs
  • Bill Gates Editorial on Fostering an Innovation Economy
  • White House Frontiers Conference on Science, Technology and Innovation

ASM President Attends UN Meeting on Combating Antimicrobial Resistance
On September 21, ASM President Susan Sharp attended the United Nations General Assembly High Level meeting on antimicrobial resistance in New York.  This was only the fourth time in the history of the UN that a health topic was discussed at the General Assembly (HIV, noncommunicable diseases and Ebola were the others).  Prior to the meeting, the ASM sent a letter to Samantha J. Power the US Ambassador to the UN urging that UN Member States unite to increase attention to the AMR challenge globally.  The UN General Assembly reaffirmed its commitment to develop national action plans on AMR based on the WHO Global Action Plan. The UN issued the resolution at the meeting on September 21.

The UN also released a report in conjuction with the resolution, “The United Nations Secretary-General's High-Level Panel on Access to Medicines Report." The ASM continues its involvement in activities and programs to combat antimicrobial resistance.  To see the history of ASM’s antimicrobial policy work go to:  http://www.asm.org/index.php/issues-we-follow/98-policy/issues/2637-antimicrobial-resistance.

Congress Passes Continuing Resolution and Funds Zika Response
On September 28, the House passed H.R. 5325 a ten-week continuing resolution (CR) that funds the federal government through December 9, 2016, at a rate of operation that is 0.496 percent below the FY 2016 level.  H.R. 5325 or the Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act, funds the Department of Veterans Affairs and related Agencies through the end of FY 2017. The remaining federal government programs are funded at FY 2016 levels, minus the 0.5 percent across-the-board cut to remain within the sequestration caps.  The bill also includes $1.1 billion in emergency supplemental funding to combat the Zika virus.  Specific funding programs include:

  • The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID) will receive $152 million for “research on the virology, natural history, and pathogenesis of the Zika virus infection and preclinical and clinical development of vaccines and other medical countermeasures for the Zika virus and other vector-borne diseases, domestically and internationally”
  • The Public Health and Social Services Emergency Fund (PHSSEF) will receive $387 million to“prevent, prepare for, and respond to Zika virus, health conditions related to such virus, and other vector-borne diseases…develop necessary countermeasures and vaccines, including the development and purchase of vaccines, therapeutics, diagnostics, necessary medical supplies…”
  • Centers for Disease Control and Prevention (CDC) will receive $394 million for CDC-Wide Activities and Program Support “to prevent, prepare for, and respond to Zika virus, health conditions related to such virus, and other vector-borne diseases” Of the $394 million, $44 million will be returned to the Public Health Emergency Preparedness cooperative agreement program which has funded Zika outbreak activities so far.

The ASM has been working to fund the federal response to the Zika virus outbreak by urging Congressional passage of a supplemental funding bill at the requested level of $1.9 billion. Since February, ASM has communicated with Congress, met with appropriators and staff, collaborated with other public health and scientific organizations and engaged the ASM membership through a legislative action alert campaign in August.  The ASM also held a one-day conference on June 1 at ASM headquarters in Washington, D.C. to stimulate basic research and bring together Zika researchers and scientists. For more information on the ASM effort to combat Zika, go to:  http://www.asm.org/index.php/issues-we-follow/137-policy/documents/statements-and-testimony/94499-zika-8-17-16.

ASM Authors Document on mcr-1 Colistin Resistance
The PSAB Committee on Laboratory Practices in Microbiology has authored a white paper on the emergence of mcr-1 plasmid-mediated colistin resistance in Gram negative pathogens.  The document includes a discussion of polymyxin antibiotics, mcr-1 and mcr-2, epidemiology and infection control.   Particularly of interest to clinical microbiologists is the section on laboratory testing which discusses pitfalls to be expected when trying to perform accurate minimum inhibitory concentration (MICs).  To read the document, go to http://www.asm.org/index.php/public-policy/93-policy/94613-colistinres-10-16.

ASM Participates in FDA Public Workshop on Antimicrobial Issues
PSAB Laboratory Practices Committee Chair Melissa Miller attended the September 29 FDA public workshop on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices and presented on behalf of ASM.  Dr. Miller focused on areas where ASM has taken the lead in antimicrobial resistance and where we could partner with the FDA on development of antimicrobial susceptibility devices.  To see the agenda and other participants in the workshop, please go to http://www.fda.gov/Drugs/NewsEvents/ucm512519.htm.  Dr. Miller’s presentation can be found at http://www.asm.org/images/PSAB/ASM-FDA-AST.pdf.  

ASM Congressional Science Fellow Secures Congressional Office Position
Laura E. Lasiter, Ph.D., ASM’s 2016-2017 Congressional Science Fellow has found a placement in the office of Senator Al Franken (D-MN).  Lassiter will be working as one of three Health Policy Fellows in the Office and will work on issues like the Affordable Care Act, Centers for Medicare and Medicaid, Children's Health Insurance Program (CHIP) reauthorization, and FDA user fees that expire in 2017.  She will primarily focus on the One Health Initiative and the renewal of the Pandemic and All-Hazards Preparedness Act (PAHPA) which expires in 2018.  The American Society for Microbiology has supported Congressional Fellows since 1977.  The ASM Congressional Science Fellowship Selection Committee selects a postdoctoral to mid-career microbiologist to spend one year on the staff of an individual member of congress, congressional committee, or with some other appropriate organizational unit of Congress.   Prospective Fellows must be citizens of the United States, members of ASM for at least one year at the time they apply and must have completed their Ph.D. by the time the fellowship begins in September.  The Congressional Science Fellowship is supported in part by the Frobisher Fund, a bequest made to ASM by Martin Frobisher.   Contact the Office of Public Affairs at publicaffairs@asmusa.org for more information on the ASM fellowship or go to the ASM web page for a program description: http://www.asm.org/index.php/congressional-science-fellowship.  The deadline for applications for the 2017 – 2018 fellowship is February 17, 2017. 

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: http://www.asm.org/index.php/public-policy/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/94641-mmm-10-16

October is National Biosafety Month
National Biosafety Month is a period during which the NIH Office of Science Policy urges institutions to refocus their attention on biosafety policies, practices and procedures.  Institutions should use National Biosafety Month as an opportunity to talk to investigators and research administrators about the importance of biosafety, raise awareness, and seek input on ways to strengthen institutional biosafety programs.

The theme of this year’s National Biosafety Month is: Evaluation, Collaboration, and Commitment.

  • Evaluate your biosafety program. Engage in self- and peer-evaluation of institutional biosafety programs and related governance structures.  The NIH Office of Science Policy has updated its Institutional Biosafety Committee Self-Assessment Tool.  This tool can be used to help evaluate your biosafety program.  Frequent review and assessment of biosafety oversight programs is key to maintaining their effectiveness.
  • Collaborate with others to promote biosafety. Share with other institutions best practices, procedures, strategies and solutions for enhancing biosafety programs.  Working with other biosafety professionals will provide a fresh perspective and may allow institutions to identify solutions to common problems.
  • Remain committed to biosafety. Ensure appropriate resources are devoted to biosafety oversight and compliance activities at your institution.  Institutions should commit to providing adequate support to ensure that all operational elements of the biosafety program have the necessary resources and can function optimally. 

House Energy and Commerce Subcommittee Holds Hearing on Dangerous Pathogens
On September 27, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing, “Bioresearch Labs and Inactivation of Dangerous Pathogens.”  The subcommittee examined  bioresearch labs and the handling of dangerous pathogens, including the 66 pathogens classified as federal “select agents.” The hearing focused on the inactivation of bacteria and viruses, or making dangerous organisms harmless and incapable of spreading disease while retaining characteristics for future use, including crucial biodefense research. This research allows for the development of diagnostic tests to detect emerging infectious diseases, as well as discovering vaccines and other medical countermeasures to protect us from epidemics.  To read the list of witnesses and their testimony go to:  https://energycommerce.house.gov/hearings-and-votes/hearings/bioresearch-labs-and-inactivation-dangerous-pathogens.

The Centers for Disease Control and Prevention Will Fund 34 Innovative Projects to Combat Antibiotic Resistance
The CDC announced that it is providing more than $14 million to fund new approaches to combat antibiotic resistance, including research on how microorganisms naturally present in the human body (referred to as a person’s microbiome) can be used to predict and prevent infections caused by drug-resistant organisms. The awards, made through CDC’s Broad Agency Announcement (BAA), support activities in the CDC Antibiotic Resistance Solutions Initiative. The initiative, which also provides funding for state health departments and other partners, implements the tracking, prevention, and antibiotic stewardship activities outlined in the National Action Plan for Combating Antibiotic-Resistant Bacteria.

The Food and Drug Administration (FDA) Released Draft Guidance for the Development of Antimicrobials and Antimicrobial Susceptibility Tests
On September 21, the FDA released draft guidance, "Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices," with comments due November 21. 

GAO Releases Report on NIH Indirect Costs
The General Accounting Office (GAO) the independent, nonpartisan agency that works for Congress, released a report in early September titled, “NIH Biomedical Research: Agencies Involved in the Indirect Cost Rate-Setting Process Need to Improve Controls.”  The GAO found that the agencies that are responsible for ensuring that negotiated indirect cost rates comply with OMB guidance and the Federal Acquisition Regulation (FAR) have not updated their internal guidance to reflect current OMB guidance or changes in agency requirements, such as documentation requirements.  The GAO provided 12 recommendations for improvements.  To read the report, go to:  http://www.gao.gov/assets/680/679587.pdf.

White House Releases Strategy to Modernize the Regulatory System for Biotechnology Products
On September 20, the White House Office of Science and Technology Policy (OSTP), the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) released a strategy to modernize the Federal regulatory system for biotechnology products.  The EPA, FDA, and USDA released two documents, a proposed Update to the Coordinated Framework for the Regulation of Biotechnology and a National Strategy for Modernizing the Regulatory System for Biotechnology Products. Together, these documents present a comprehensive summary of the current roles and responsibilities of the three primary regulatory agencies with respect to the regulation of biotechnology products and a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.

Bill Gates Editorial on Fostering an Innovation Economy
An editorial by Bill Gates was published in the digital publication, Quartz, outlining four recommendations for the next President for fostering an innovation economy:

  1. Provide everyone on earth with affordable energy without contributing to climate change.
  2. Develop a vaccine for HIV and a cure for neurodegenerative diseases.
  3. Protect the world from future health epidemics, which might be more infectious than Ebola and more deadly than Zika.
  4. Give every student and teacher new tools so that all students get a world-class education.

Gates believes, “innovation starts with government support for research labs and universities working on new insights that entrepreneurs can turn into companies that change the world. The public sector’s investments unlock the private sector’s ingenuity.”

White House Frontiers Conference on Science, Technology and Innovation
President Obama is hosting a day-long White House Frontiers Conference in Pittsburgh to encourage Americans to imagine our Nation and the world in 50 years and beyond, and to explore America’s potential to broaden participation and advance towards the frontiers that will make the world healthier, more prosperous, more equitable, and more secure.  The conference, co-hosted by the White House, the University of Pittsburgh, and Carnegie Mellon University, brings together researchers, business leaders, technologists, philanthropists, local innovators, and students who are the change-makers of tomorrow on these five frontiers.  To read a fact sheet about the conference go to:  https://www.whitehouse.gov/the-press-office/2016/10/13/fact-sheet-harnessing-possibilities-science-technology-and-innovation

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