e-Public Policy Update - March 2016

Contents:

  • Public and Scientific Affairs Board Meeting
  • ASM Comments on Select Agent Regulations
  • ASM Submits Congressional Testimony on FY 2017 Research and Public Health Funding
  • ASM Participates in S-FAR Congressional Briefing
  • ASM Attends Congressional Hearing on Zika Virus
  • ASM Attends FDA Pharmacy Compounding Advisory Committee Meeting
  • PSAB Committees Co-Authors CIDT Interim Guideline
  • NAS Gain of Function Workshop
  • ASM Supports Emergency Funding to Combat the Zika Virus Outbreak
  • NIH Office of Science Policy Announces Policy Blog
  • Minority Microbiology Mentor Newsletter

Public and Scientific Affairs Board Meeting
The ASM Public and Scientific Affairs Board (PSAB) held its annual meeting at ASM Headquarters on February 5.  Members of the Board and ASM leadership engaged in discussion with key policy makers from federal agencies who presented and discussed programs and activities of interest to the microbiological community.  The following speakers presented at the meeting: Anthony S. Fauci, M.D., Director, National Institute for Allergy and Infectious Diseases, Lawrence A. Tabak, D.D.S., Ph.D., Principle Deputy Director, National Institutes of Health, Stephen M. Ostroff, M.D., Acting Commissioner of Food and Drugs, Food and Drug Administration, Rima Khabbaz, M.D., Director for Infectious Diseases, Centers for Disease Control and Prevention, COL Matthew Hepburn, M.D., Program Manager, Biological Technologies Office (BTO), Defense Advanced Research Projects Agency (DARPA), Andrew Hebbeler, Ph.D., Senior Science, Technology, and Innovation Adviser, Jessica Petrillo, Ph.D., Senior Health Security Officer at the U.S. Department of State and Dennis Carroll, Ph.D., Director, Pandemic Influenza and other Emerging Threats Unit, US Agency for International Development’s (USAID).

ASM Comments on Select Agent Regulations
In March, the ASM sent comments to the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) regarding changes to the list of Select Agents and Toxins and enhanced biosafety requirements, in response to the Biennial Reviews published in the Federal Register on January 19, 2016.  The comments addressed the removal of certain agents and proposed new requirements to clarify the regulatory language and to address concerns related to inactivation of select agents, biosafety procedures and confirmed identification of a select agent.  To read the ASM comments and the Federal Register notices go to:  http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/94078-sa-3-16

ASM Submits Congressional Testimony on FY 2017 Research and Public Health Funding
In March, ASM submitted written testimony to the House and Senate appropriations subcommittees on FY 2017 funding for federal research and public health programs impacting microbiology.  The statements included recommendations for the National Institutes of Health (NIH), Food and Drug Administration (FDA), Department of Agriculture (USDA) Research, Department of Energy, Office of Science (DOE), Centers for Disease Control and Prevention (CDC), National Science Foundation (NSF) and the Department of Defense (DOD) medical research programs.  To read the testimony go to:  http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/94075-fy-2017.

ASM Participates in S-FAR Congressional Briefing
On February 24th, ASM joined the other members of the U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR) in a briefing discussing the public health crisis of antimicrobial resistance (AR) and related programs in the President’s Budget Request for Fiscal Year 2017.  Attendees had the opportunity to hear clinician and patient perspectives on infections with AR organisms and were able to interact with federal agency officials who are working to implement the “National Action Plan for Combating Antibiotic-Resistant Bacteria”.   S-FAR is a national partnership and was convened on the principle that any U.S. government strategy to address antimicrobial resistance should involve sustained and meaningful engagement with non-government experts and stakeholders throughout the development and implementation process.  Read more about S-FAR here: http://s-far.org/

ASM Attends Congressional Hearing on Zika Virus
On February 24, ASM staff attended “The Zika Virus: Coordination of a Multi-Agency Response” hearing held by the House Committee on Oversight and Government Reform.  Presenting the history of Zika virus and current federal government strategies were Anne Schuchat, Principal Deputy Director of the Centers for Disease Control and Prevention (CDC) and Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases (NIAID).  John Armstrong, the Surgeon General and Secretary of Health of the State of Florida, and Bill Moreau, Managing Director for Sports Medicine for the United States Olympic Committee raised specific concerns about mosquito eradication and risks to U.S. athletes.  To see the hearing in its entirety, see https://oversight.house.gov/hearing/the-zika-virus-coordination-of-a-multi-agency-response/.

ASM Attends FDA Pharmacy Compounding Advisory Committee Meeting
ASM Staff attended the March 8-9 U.S. Food and Drug Administration (FDA) Pharmacy Compounding Advisory Committee Meeting (PCAC) meeting in Silver Spring, MD.   The portion of the meeting of interest to ASM members involved the discussion of quinacrine hydrochloride and its use as an anti-parasitic treatment, an anti-lupus treatment and for intrauterine sterilization.  All materials from the meeting can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PharmacyCompoundingAdvisoryCommittee/ucm486094.htm

PSAB Committees Co-Authors CIDT Interim Guideline
Members of the PSAB Committees on Laboratory Practices and Professional Affairs joined the Association of Public Health Laboratories (APHL) Culture-Independent Diagnostics (CID) Subcommittee to author “Interim Guideline: Submission of Enteric Pathogens from Positive Culture-independent Diagnostic Test Specimens to Public Health.” This document is intended to assist clinical laboratory personnel in submitting required isolates to public health laboratories.  The guidance applies to isolates and specimens that are positive by culture independent diagnostic tests (CIDTs) since nationally recommended practices for the public health submission of specimens that test positive using CIDTs are not available to clinical microbiologists.  To read the document, go to http://www.aphl.org/AboutAPHL/publications/Documents/FS-Enteric_Pathogens_Guidelines_0216.pdf.

NAS Gain of Function Workshop
The “Gain-of-Function Research: The Second Symposium” was held by the National Academies of Sciences, Engineering, and Medicine on March 10-11.  This public meeting was the Academies' second gathering to provide a mechanism to engage the life sciences community and the broader public and solicit feedback on optimal approaches to ensure effective federal oversight of gain of function (GOF) research.  Among those participating were officials from the Office of Science and Technology Policy, the U.S. Food and Drug Administration, the National Institutes of Health, the Departments of Health and Human Services and Homeland Security, and the World Health Organization.  View the meeting agenda by going to http://dels.nas.edu/resources/static-assets/bls/agenda/GOFagendafinal.pdf.

ASM Supports Emergency Funding to Combat the Zika Virus Outbreak
ASM wrote key members of the Senate and House of Representatives Appropriation Committees in support of the President’s request of $1.8 billion for emergency supplemental funding to prepare for and respond to the Zika virus outbreak.  The new resources requested will help build on existing preparedness efforts and will support strategies to combat Zika both at home and abroad.  ASM specifically supports efforts to accelerate both vaccine and rapid diagnostic test development, for which $200 million is requested, and the establishment of a new Urgent and Emerging Threat Fund ($210 million) which will go toward improving epidemiology and expanding laboratory and diagnostic capacity.   To read the letter in full, go to https://www.asm.org/images/ASM_February_12_Letter_to_Congress.pdf.  

NIH Office of Science Policy Announces Policy Blog
The National Institutes of Health wanted ASM members to be aware that the Office of Science Policy (OSP) has a blog “Under the Poliscope: Bringing Science Policy Into Focus,” which highlights the activities of the NIH Office of Science Policy and focuses on science policy matters in general as well as emerging issues of interest to the life sciences community and public at large. NIH encourages readers to provide their thoughts and ideas to stimulate a dialogue between NIH and its stakeholders.  To subscribe to “Under the Poliscope,” click the following link: http://osp.od.nih.gov/under-the-poliscope.

Minority Microbiology Mentor Newsletter
The March 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/publicpolicy-2/newsletters/minority-microbiology-newsletter/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/94073-mmm-3-16.

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