e-Public Policy Update - December 2015

Contents:

  • ASM Comments on Fast-Track Action Report on Mapping the Microbiome
  • ASM Participates in Antibiotic Resistance Working Group Meeting
  • ASM Comments on Proposed Changes to Human Subject Protection Regulations
  • ASM Comments on Identifying Sources of Agricultural Innovation
  • ASM Participates in Unifying Message Discussion
  • ASM Attends House Hearing on Lab Developed Test Regulation
  • ASM Attends CLIAC Meeting on LDTs
  • National Institutes of Health NIH-Wide Strategic Plan Preview
  • National Science Advisory Board for Biosecurity (NSABB) Meeting
  • Minority Microbiology Mentor Newsletter

ASM Comments on Fast-Track Action Report on Mapping the Microbiome
In December the Life Sciences Subcommittee of the National Science and Technology Council (NSTC) released the Report of the Fast-Track Action Committee on Mapping the Microbiome.  The full report which can be found at https://www.whitehouse.gov/sites/default/files/microsites/ostp/NSTC/ftac-mm_report_final_112015_0.pdf, recognizes that doing diverse scientific research on the world’s ubiquitous communities of microorganisms offers “vast potential to improve plant, animal, and human health, to mitigate climate change, and to promote industrial innovation.”  The ASM sent an advisory to ASM members asking for comments on the report.  On December 2, the ASM sent letters to John P. Holdren, Ph.D. Director, Office of Science and Technology Policy and Shaun Donovan, Director of the Office of Management and Budget in support of the recommendations in the report.  The ASM cautioned that new funding for the microbiome should not be at the expense of basic research and noted that the field of mycology should be included in any initiative.

On December 4, Dr. Ronald Atlas, Chair of the ASM’s Public and Scientific Affairs Board, Timothy Donohue, Past President of ASM and Janet Shoemaker, Director, ASM Office of Public Affairs had meetings with Dr. Anthony Fauci, Director, National Institutes of Allergy and Infectious Diseases, NIH and Dr. Sharlene Weatherwax, Associate Director of Science for Biological and Environmental Research and Dr. Todd Anderson, Director, Biological Systems Science Division of the Department of Energy to discuss microbiome research.  To read the ASM letter and advisory go to:  http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93869-microbiome-12-15.  .

ASM Participates in Antibiotic Resistance Working Group Meeting
ASM President-Elect Susan Sharp was invited as an ASM representative to participate in a teleconference with the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) Working Group on One Health Surveillance on December 8.  Dr. Sharp presented responses to questions submitted by the Working Group on optimization of the interactions between Federal laboratories to address the continued problem of antimicrobial-resistant bacteria, utilization of governmental repositories of antimicrobial resistant organisms, and ways to tie data from human and veterinary sources together to assess resistance organisms in a holistic manner.  See the comments at http://www.asm.org/index.php/public-policy/98-policy/issues/93873-paccarb-12-16.

ASM Comments on Proposed Changes to Human Subject Protection Regulations
In November, ASM commented on the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking, better known as the Common Rule.  Most comments focused on the need for de-identified human specimens for routine validation of diagnostic tests and research that does not involve analysis of human genetic material.  You can view them online at http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93868-hp-11-19-15

ASM Comments on Identifying Sources of Agricultural Innovation
In December, the Public and Scientific Affairs Board (PSAB), Committee on Agricultural and Food Microbiology responded to a Request for Information (RFI) from the Office of Science and Technology Policy (OSTP) about identifying sources of agricultural innovation. The committee identified a number of research gaps and recommended that the administration focus efforts on funding R&D in areas including; antigenically variable viruses, microbiome, antimicrobial resistance and climate variability.  A copy of the letter can be found on the ASM public policy webpage at:  http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93872-ag-rfi-11-15

ASM Participates in Unifying Message Discussion
The ASM participated in a December meeting convened by the Charles Valentine Riley Memorial Foundation (RMF) at the American Association for the Advancement of Science (AAAS) in Washington, D.C., as one of twenty-seven invited U.S. scientific societies active in food, agricultural and natural researches research.  The meeting resulted from a 2014 report produced by RMF, Iowa State University, Mississippi State University, Soil and Water Conservation Society, Texas Tech University and Colorado State University that identified the need for a unified message to support increased funding for food and agricultural research. 

ASM Attends House Hearing on Lab Developed Test Regulation
On November 17, ASM staff attended the House Energy and Commerce Health subcommittee hearing “Examining the Regulation of Diagnostic Tests and Laboratory Operations.”  Jeffrey Shuren, Director of the Center for Devices and Radiological Health, Food and Drug Administration (FDA), and Patrick Conway, Deputy Administrator for Innovation and Quality & Chief Medical Officer, Centers for Medicare and Medicaid Services, served as witnesses on the topic of  FDA’s Proposal for Oversight of Laboratory Developed Tests (LDTs). LDTs are in vitro diagnostic tests intended for clinical use and designed, manufactured, and used within a single clinical laboratory; the FDA is expected to issue final guidance on the regulation of these tests in 2016.  The availability of LDTs, especially molecular tests to identify infectious agents, may be affected by what is included in the final guidance.  You can view the full hearing at http://energycommerce.house.gov/hearing/%E2%80%9Cexamining-regulation-diagnostic-tests-and-laboratory-operations

ASM Attends CLIAC Meeting on LDTs
The Clinical Laboratory Improvement Advisory Committee (CLIAC) met November 18-19 and discussed the Interoperability of Laboratory Data, non-invasive prenatal testing and the FDA Laboratory Developed Test Guidance.  Additionally, new CLIAC members were introduced, including former ASM Division C Chair Sheldon Campbell.  CLIAC provides scientific and technical advice and guidance to the Department of Health and Human Services (HHS) and includes diverse membership across laboratory specialties, professional roles, and practice settings, and includes a consumer representative.  To read more about the meeting and CLIAC, see http://wwwn.cdc.gov/cliac/.   

National Institutes of Health NIH-Wide Strategic Plan Preview
In December the NIH previewed a revised "NIH-Wide Strategic Plan," presented at the Advisory Committee to the Director meeting by Lawrence A. Tabak, DDS, Ph.D., principal deputy director of the NIH. The plan includes a new objective, "Excel as a federal science agency by managing for results," which involves evaluating scientific outputs, creating a dynamic model of the biomedical workforce, and tracking the effectiveness of decision making, among others. The document is a preview of a final version of the plan, which will be presented to Congress.  The ASM sent comments on the framework for the strategic plan in August. To read those comments go to:  http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93633-nih-sp-8-17-15.  To read the preview of the plan go to:  http://acd.od.nih.gov/presentations/NIH-Wide-Strategic-Plan-12082015.pdf.

National Science Advisory Board for Biosecurity (NSABB) Meeting
The next meeting of the NSABB will take place on January 7 and 8, 2016, from 8:30 am - 5:30 pm and 8:30 am - 2:15 pm (Eastern) respectively, at the National Institutes of Health, Building 31, C Wing, 6th Floor Conference Room 6, in Bethesda, Maryland.

The following items are on the Board's agenda:

  • Preliminary findings of the NSABB Working Group on Evaluating the Risks and Benefits of Gain-of-Function (GOF) Studies
  • Results of the draft risk and benefit assessments of GOF studies involving pathogens with pandemic potential
  • Ethical and policy issues relevant to the conduct and oversight of GOF studies
  • Other business of the Board

The agenda, registration information, and other meeting material will be posted to the NSABB meeting web page as they become available.  The meeting will be webcast and viewable at http://videocast.nih.gov while the meeting is in session.  For more information, contact Christopher Viggiani, NIH Office of Science Policy, by email at viggianic@od.nih.gov or by telephone at 301-496-9838.

Minority Microbiology Mentor Newsletter
The December issue of the Minority Microbiology Newsletter has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM). You can read the newsletter by going to this link:  http://www.asm.org/index.php/publicpolicy-2/newsletters/minority-microbiology-newsletter/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93880-mmm-12-15.  

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