e-Public Policy Update - September 2015

Contents:

  • ASM Comments on the List of Select Agents and Toxins
  • 21st Century Cures Act Passes the House
  • ASM Endorses Letter to Senate HELP Committee on NIH
  • ASM Comments on NIH RFI on the Framework for the NIH-wide Strategic Plan
  • ASM Comments on Department of State and Commerce Control Regulations for Certain Pathogens
  • ASM Meeting at DARPA
  • ASM Supports Increased Funding for Biodefense
  • NIH Salary Limit Reductions Coalition Letter
  • Research and Development Appropriations Update
  • ASM Supports Agricultural Research on Capitol Hill
  • Federal Agencies to Update the Coordinated Framework for the Regulation of Biotechnology
  • ASM and APHL Draft HIV Western Blot White Paper
  • TJC Laboratory PTAC Selects ASM Member Vice Chair
  • Former Professional Affairs Chair Invited to CMS Panel
  • ASM Staff Attends APUA Antibiotic Stewardship Seminar 
  • ASM Sends Request for Personal Stories About S&T Meetings
  • ASM Presents at June CCCLW Meeting
  • ASM Participates in S-FAR Summer Series
  • ASM Presents at Annual CMS Clinical Lab Fee Schedule Meeting
  • FedEx Discontinues Transport of Select Agents
  • ASM Attends DURC Stakeholder Workshop
  • Minority Microbiology Mentor Newsletter

ASM Comments on the List of Select Agents and Toxins
The ASM submitted comments to the Centers for Disease Control and Prevention on the possession, use, and transfer of select agents and toxins.  The comments addressed adding certain Influenza virus strains to the List of Select Agents and Toxins.  To read the ASM’s comments go to:  https://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93640-sa-8-24-15.

21st Century Cures Act Passes the House
In July, the 21st Century Cures Act (H.R. 6) was approved by the House by a vote of 344-77.  The nonpartisan legislation includes provisions to improve the US health care system, to invest in science and medical innovation, to incorporate the patient perspective, to modernize clinical trials and to deliver better, faster cures to patients.  The legislation would reauthorize the National Institutes of Health (NIH) for three years at funding levels that represent an increase of $1.5 billion per year and provide $8.75 billion over the next five years in mandatory funding through an NIH Innovation Fund.  The ASM sent a letter of support to the bill’s authors, House Energy and Commerce Committee Chairman Fred Upton (R-MI), Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO) and is listed as one of the over 700 supporters of the legislation.  To read the ASM’s letter go to:  http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93512-cures-5-8.

ASM Endorses Letter to Senate HELP Committee on NIH
The ASM signed onto a letter to the Senate Committee on Health, Education, Labor and Pensions commending them on their action about the critical role of the NIH.  The committee is currently drafting legislation to enhance the role of NIH.  The letter was sent to Senate HELP Committee Chair Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) praising them for their leadership and vision in undertaking a bipartisan initiative to examine the role of NIH in getting safe treatments, devices and cures to patients. The letter offers a number of recommendations as the HELP Committee begins to draft legislation to enhance the role of NIH, including:

•           Stabilize the NIH Budget Through Sustained Increases in Appropriations;
•           Affirm Existing NIH Support for Interdisciplinary Scientific Research;
•           Grant NIH “Carry-Over” Budget Authority;
•           Ease the Burdensome Travel Restrictions for Federal Researchers; and
•           Address Regulatory Burden.

The entire letter is available on the ASM web page at:  http://www.asm.org/images/PSAB/NIH-HELP-6-15.pdf.

ASM Comments on NIH RFI on the Framework for the NIH-wide Strategic Plan
In August, the ASM submitted comments to the National Institutes of Health (NIH) RFI on the Framework for the NIH-wide Strategic Plan.  The comments will help NIH develop a 5-year strategic plan to outline a vision for biomedical research that will pursue fundamental knowledge about the nature and behavior of living systems and apply that knowledge to extend healthy life and reduce illness and disability.  A description of the NIH’s strategic plan project is available at:  http://www.nih.gov/about/strategic-plan/.  The ASM comments are posted on the web at:  https://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93633-nih-sp-8-17-15.  

ASM Comments on Department of State and Commerce Control Regulations for Certain Pathogens
The ASM submitted comments to the US Department of State and Department of Commerce regarding the Category XIV materials (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment) included on the United States Munitions List and the Commerce Control List.  The ASM also addressed the proposed definition of fundamental research in the regulations, which is problematic and fails to adequately encompass the full scope of activities and outcomes of such research.  The ASM pointed out that the too narrow definition has significant impacts on both the research community and the export of US technology.  To read the comments go to:  https://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93632-bis-8-17-15.  

ASM Meeting at DARPA
In July, Ronald Atlas, Chair of the Public and Scientific Affairs Board, Kenneth I. Berns, Chair, Committee on Biodefense and Janet Shoemaker, Director, ASM, Office of Public Affairs met with program officials from the Defense Advanced Research Projects Agency (DARPA) to discuss microbiology research.  The mission of DARPA is to make pivotal investments in breakthrough technologies for national security.  They met with COL Matthew Hepburn, MD, Program Manager, Biological Technologies Office.  This office addresses the dynamic threats of emerging infectious diseases. 

ASM Supports Increased Funding for Biodefense
In August, the ASM signed onto a letter from the Informal Coalition on Biodefense and Public Health Preparedness expressing concern over the funding levels for programs critical to the nation’s preparedness against threats both naturally occurring, like Ebola and pandemic influenza, and deliberate, such as chemical, biological, radiological or nuclear (CBRN) events.  The letter pointed out that the $255 million funding levels included in the Senate and House FY 2016 Appropriations bills are not sufficient to build and maintain key capabilities to prepare for public health emergencies.  To read the entire letter go to: http://www.asm.org/images/PSAB/Biodefense-House-8-15.pdf.

NIH Salary Limit Reductions Coalition Letter
In August, the ASM signed onto a letter requesting that the House Appropriations Committee reject a proposal to reduce the salary limit imposed on extramural researchers funded by the Department of Health and Human Services (HHS) to Level III of the Executive pay scale.  Section 203 of the FY 2016 Labor-HHS appropriations would reduce the salary limit on HHS extramural grants from Executive Level II to Executive Level III ($168,700 in 2015), a cut of $14,600 (8 percent). This cut follows a $20,000 (10 percent) cut from Executive Level I to Executive Level II in the FY 2012 funding bill.  Lowering the extramural salary limit particularly disadvantages the most productive investigators who have a sustained track record in breakthrough discoveries, and will have a chilling effect on research institutions’ ability to recruit and retain the most gifted new investigators.  The letter urged congressional appropriators to retain the extramural salary limit at Executive Level II, which will help institutions continue to attract and retain the most talented investigators.  To read the entire letter go to: http://www.asm.org/images/PSAB/FY-2016-Salary-cap.pdf.

Research and Development Appropriations Update
In July, the fiscal year (FY) 2016 appropriations process continued in Congress.  Highlights of spending bills of interest to the ASM membership include:

On June 25, the Senate Appropriations Committee approved its FY 2016 Labor, Health and Human Services, Education, and Related Agencies Appropriations Act (Labor-HHS) The spending bill would fund the National Institutes of Health (NIH) at $32 billion, nearly $2 billion above the FY 2015 enacted level; with $200 million for precision medicine;  $135 million for the BRAIN initiative, or a $70 million increase, $664 million for Combating Antibiotic Resistant Bacteria (CARB) a cooperative effort between the NIH, BARDA, CDC and the Agency for Healthcare Research and Quality (AHRQ).  The Centers for Disease Control (CDC) would receive $6.7 billion, a $215 million decrease from the FY 2015 enacted level and $355 million below the FY 2016 House level.

On July 15, the House Appropriations Committee recommended a total $31.2 billion for the NIH, $1.1 billion above the fiscal year 2015 enacted level and $100 million above the President’s budget request.  The bill provides increases for several targeted research initiatives, including $886 million, a $300 million increase, for an Alzheimer’s disease research initiative; $461 million, a $100 million increase, for an antibiotic resistance initiative; $150 million, a $95 million increase, for the Brain Research through Application of Innovative Neuro-technologies (BRAIN) initiative; and the full $200 million requested for the Precision Medicine Initiative (PMI).  The legislation includes a total of $7 billion for the CDC, $140 million above the fiscal year 2015 enacted level and equal to the budget request.

On July 14, the Senate Appropriations Agriculture Subcommittee marked its FY 2016 draft spending bill to fund the Department of Agriculture (USDA) and Food and Drug Administration (FDA).  The bill proposes funding: the USDA Animal and Plant Health Inspection Service (APHIS) with $876 million; The Food Safety and Inspection Service (FSIS) with $1 billion; $325 million for the Agriculture and Food Research Initiative (AFRI).  The bill includes a $45 million increase for the FDA to implement the Food Safety Modernization Act of 2010. 

For more updates go to the Public Policy web page:  http://www.asm.org/policy.

ASM Supports Agricultural Research on Capitol Hill
On July 14, PSAB staff attended the Supporters of Agricultural Research (SoAR) Foundation’s inaugural event on Capitol Hill. ASM is a founding member of SoAR, a new non-partisan coalition of scientific societies, universities and other groups with an interest in agricultural and food research.  SoAR supports full funding for the Agricultural and Food Research Initiative (AFRI), the USDA’s competitive grants program.  For more information on SoAR, including a list of members, please visit: http://supportagresearch.org/

On July 7, the Senate Committee on Agriculture, Nutrition and Forestry held a hearing on Highly Pathogenic Avian Influenza (HPAI) and its impact on the U.S. poultry industry.  The hearing stressed the importance of research to combat both the current and future outbreaks and highlighted the Department of Agriculture’s (USDA) Animal Plant and Health Inspection Service (APHIS) current work on vaccine development. The PSAB Committee on Agricultural and Food Microbiology is monitoring this issue.  

Federal Agencies to Update the Coordinated Framework for the Regulation of Biotechnology
In July, the White House issued a Memorandum to the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and Department of Agriculture (USDA), ordering an update to the Coordinated Framework for the Regulation of Biotechnology, first issued by the White House Office of Science and Technology Policy (OSTP) in 1986, and last updated in 1992.  The memorandum also directs the FDA, EPA and USDA to develop long-term strategies to prepare for the future of biotechnology and related products.  A copy of the full memo can be found: https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf.   

ASM and APHL Draft HIV Western Blot White Paper
Members of the PSAB Laboratory Practices and Professional Affairs committees joined the Association of Public Health Laboratories (APHL) HIV and Viral Hepatitis Subcommittee to assist in preparation of “Limitations for the Use of HIV-1 Western Blot in Plasma/Serum.”  This document supports the discontinuation of HIV-1 Western blot testing in concert with the Centers for Disease Control and Prevention (CDC) and APHL’s newly published laboratory algorithm for HIV diagnosis, “Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations.”   This algorithm replaces previous HIV laboratory testing guidelines and is expected to help with earlier identification of HIV infections.  See the ASM/APHL document at http://www.asm.org/images/PSAB/HIV-1-1-WesternBlotBrief.pdf for more details.   

TJC Laboratory PTAC Selects ASM Member Vice Chair
PSAB Laboratory Practices committee member Yvette McCarter has been selected Vice Chair of the Joint Commission’s (TJC) Laboratory Professional and Technical Advisory Committee (Lab PTAC) and represented the ASM on a June 23 conference call.  This committee is responsible for the development and refinement of standards and elements of performance in clinical laboratories.  The Joint Commission accredits and certifies more than 20,500 health care organizations and programs in the United States and PTACs are an integral part of TJC’s advisory structure and represent the views of a diverse group of professional associations and other interests and by providing expert advice.  To read more about Lab PTAC, go to http://www.jointcommission.org/accreditation/laboratory_ptac.aspx.  

Former Professional Affairs Chair Invited to CMS Panel
The University of Tennessee Professor Vickie Baselski, former Chair of the PSAB Professional Affairs committee, has been invited to serve on the Centers for Medicare and Medicaid (CMS) Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel).  The Panel was authorized by the Protecting Access to Medicare Act of 2014 (PAMA), enacted April 1, 2014, and is charged with providing expertise related to clinical diagnostic tests.  One of the tasks the Panel will undertake is the establishment of payment rates for new clinical diagnostic laboratory tests.  Learn more about the panel by reading the Federal Register notice here http://www.gpo.gov/fdsys/pkg/FR-2014-10-27/pdf/2014-25401.pdf.  

ASM Staff Attends APUA Antibiotic Stewardship Seminar
The Alliance for the Prudent Use of Antibiotics (APUA) offered a webinar presented by Geraldine Hall entitled “Rapid Diagnostics in Clinical Microbiology as an Aid to Antibiotic Stewardship” on June 16, which ASM staff attended.  The seminar focused on a detailed explanation of rapid non-culture identification methods and their unique role in antibiotic stewardship programs, improved patient outcomes, and lowered healthcare costs.  The Alliance for the Prudent Use of Antibiotics (APUA) has been a leading global non-governmental organization working to preserve the effectiveness of antibiotics for nearly 35 years.  To read more about APUA and view the webinar materials, go to http://www.tufts.edu/med/apua/.   

ASM Sends Request for Personal Stories About S&T Meetings
The ASM is a member of a coalition of societies working with the American Association for the Advancement of Science (AAAS) to encourage governmental support for scientific meetings. Funding for scientific meetings and for federal scientists to attend these meetings has been cut drastically. The AAAS asked scientists to provide stories highlighting the important role that meetings play in advancing science. Through personal anecdotes the key role of scientific meetings can be demonstrated for those making federal policy regarding travel and meetings. The AAAS plans to compile stories from various disciplines and communicate them to Congress and federal agencies to show the value of science and technology meetings.  If you would like to participate in the campaign go to:   http://www.aaas.org/yourstory. . An overview of the campaign is available at: http://www.aaas.org/call-for-conference-stories.

ASM Presents at June CCCLW Meeting
PSAB Professional Affairs Committee member Janice Matthews-Greer attended the Coordinating Council on the Clinical Laboratory Workforce (CCCLW) meeting on June 29 in Chicago, IL.  Dr. Matthews-Greer highlighted ASM’s educational efforts on behalf of clinical laboratory professions and participated in discussions on patient outcome data.  The CCCLW is a coalition of laboratory organizations working together to ensure a high quality workforce by increasing the number of qualified clinical laboratory professionals, increasing public awareness of  clinical scientists’ value in achieving positive patient outcomes, and enhancing the image of clinical laboratory professionals.  More about the organization can be found at http://www.ccclw.org/.

ASM Participates in S-FAR Summer Series
The U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR) presented a series of webinars between July and August 2015 on various areas of concern in antimicrobial resistance.  ASM staff participated in “S-FAR Summer Series #1: Antimicrobial Stewardship and Data Collection Components of the National Action Plan - Human Medicine” on July 15; "S-FAR Summer Series #2: Stewardship, Data Collection, and Research Components of the National Action Plan - Veterinary Medicine" on July 30; and "S-FAR Summer Series #3: Research & Development (R&D) and Incentive Components of the CARB National Action Plan" on August 20.  S-FAR is a national partnership convened by the Infectious Diseases Society of America (IDSA) consisting of over 70 national health organizations.  You can learn more about the S-FAR partnership by going to http://www.s-far.org/.

ASM Presents at Annual CMS Clinical Lab Fee Schedule Meeting
On July 16, ASM presented comments at the annual Public Meeting Regarding the Clinical Laboratory Fee Schedule for CY 2016 at the Centers for Medicare & Medicaid Services (CMS) in Baltimore, MD.  This meeting allows stakeholder input on the basis of payment and the amount of payment by CMS for clinical laboratory tests introduced each calendar year.  To read ASM comments and see the meeting agenda, please go to http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93598-clfs-7-15.

FedEx Discontinues Transport of Select Agents
On July 17, FedEx notified federal agencies that they would no longer accept Select Agents for transport on FedEx Express.   Because FedEx is a large multi-national shipping company, many laboratories that identify and ship biological select agents and toxins may be affected by this decision.  Recently, a national medical courier organization assembled a list of couriers who offer transport of medical specimens, many of them willing to carry Select Agents.  To see this list, click the link and join https://integritydelivers.webconnex.com/MedCourierCnxMemberList.

ASM Attends DURC Stakeholder Workshop
On July 22, ASM staff attended the USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) Stakeholder Engagement Workshop, a public meeting co-hosted by The White House Office of Science and Technology (OSTP) Policy and the National Institutes of Health (NIH).   The purpose of the meeting was for interested stakeholders to discuss their experiences and challenges in the implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences DURC (the Policy).  There were interactive case studies that illustrated the factors that investigators and institutions consider when determining whether research is subject to the Policy as well as a series of panels comprised of institutional representatives to share their respective approaches to the Policy.  To see the resources from this Workshop, please go to http://www.phe.gov/about/OPP/DURCworkshop/Pages/overview.aspx.

Minority Microbiology Mentor Newsletter
The August 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:  https://www.asm.org/index.php/publicpolicy-2/newsletters/minority-microbiology-newsletter/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93625-mmm-8-15.

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