e-Public Policy Update - May 2015

Contents:

  • Public and Scientific Affairs Board Sponsoring Federal Funding Opportunities Breakfast at asm2015
  • ASM Comments on the 21st Century Cures Act
  • ASM Letter to Science Committee on America COMPETES Reauthorization Act of 2016
  • ASM Endorses 302(b) Allocation Increase for Health and Human Agencies
  • US Government to Hold a Public Stakeholder Meeting on Institutional Oversight of Dual Use Research of Concern
  • FDA Invites ASM to Expand Duodenoscope Culture Standards
  • ASM Joins S-FAR Webinar on S.185, the PATH Act
  • FDA and CMS Form Task Force on LDT Requirements
  • Public and Scientific Affairs Board asm2015 Special Interest Symposiums
  • Minority Microbiology Mentor Newsletter
  • Committee on the Status of Women in Microbiology Communicator – Spring 2015

Public and Scientific Affairs Board Sponsoring Federal Funding Opportunities Breakfast at asm2015
Attend the Federal Funding Opportunities Breakfast at asm2015 in New Orleans, LA
Sponsored by the Public and Scientific Affairs Board
Monday, June 1 | 8:00 a.m. – 9:00 a.m.
Ernest N. Morial Convention Center, Meeting Room 242

Enjoy a continental breakfast while learning about funding opportunities available to microbiologists from several federal agencies that support biomedical, environmental and life sciences research.

Moderated By:

Charles W. Rice, Ph.D.
Chair, Committee on Agricultural and Food Microbiology
Public and Scientific Affairs Board

Featured Presenters:

Shiva P. Singh, Ph.D.
Chief, Undergraduate and Predoctoral Training Branch
Division of Training, Workforce Development, and Diversity
National Institute of General Medical Sciences
National Institutes of Health

Elizabeth R. Blood, Ph.D.            
NEON Program Director
National Science Foundation

Joseph R. Graber, Ph.D.
Program Manager, Team Lead for Genomic Science
Biological Systems Science Division
Office of Biological & Environmental Research
U.S. Department of Energy

ASM Comments on the 21st Century Cures Act
The ASM sent comments on the 21st Century Cures Initiative to the House Committee on Energy and Commerce.  The bill aims to stimulate both innovation in biomedical research and the development of new medical treatments and cures. The ASM applauded the Act’s $10 billion increase in National Institutes of Health (NIH) funding over five years, which is intended to be mandatory funding outside the annual appropriations process.  This proposed increase would provide needed additional support for the NIH, which funds much of the Nation’s biomedical discoveries.  The bill’s authorization of an additional $1.5 billion in discretionary funding for each of the next 3 years will help to set NIH on a path to growth after years of stagnant funding.  The ASM made recommendations on the $10 billion NIH Innovation Fund, the Biomedical Research Working Group, travel for NIH supported scientists to scientific meetings and conferences and interagency cooperation between the NIH, Food and Drug Administration and the Centers for Disease Control and Prevention on the development of new antimicrobials.  To read the ASM letter go to: https://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93512-cures-5-8.

ASM Letter to Science Committee on America COMPETES Reauthorization Act of 2016
The ASM sent a letter to members of the House Committee on Science, Space and Technology concerning provisions in the America Competes Reauthorization Act of 2016, H.R. 1806.  The ASM is concerned that certain provisions of the Act would underfund discovery research supported by the National Science Foundation (NSF) and the Department of Energy (DOE) Office of Science.  The ASM supports strong funding across all disciplines of basic scientific research as a top national priority and urged Congress to provide steady and sustained growth in funding by setting robust authorization levels for the NSF and the DOE Office of Science.  To read the letter go to:  http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93470-doe-nsf-2016.

ASM Endorses 302(b) Allocation Increase for Health and Human Agencies
The ASM signed onto a letter, as a member of the Coalition for Health Funding (CHF), to the House of Representatives Committee on Appropriations urging them to restore the Fiscal Year 2016 302(b) allocation for the Labor, HHS, Education and Related Agencies Appropriations Subcommittee to at least the FY 2010 level of $163.6 billion.  To read the coalition letter go to:  http://www.asm.org/images/PSAB/FY2016-LHHS302b.pdf.

US Government to Hold a Public Stakeholder Meeting on Institutional Oversight of Dual Use Research of Concern
The White House Office of Science and Technology Policy and the National Institutes of Health will co-host a public meeting for interested stakeholders to discuss implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. The purpose of the meeting is to inform and engage stakeholders; collect feedback about resources needed to effectively implement the policy; and discuss stakeholder experiences, challenges, and innovative practices.

The meeting will be held on July 22, 2015, from 9:00 a.m. to 4:45 p.m. in the Building 10 Lipsett Amphitheatre on the campus of the National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892.

Pre-registration for the meeting is required. Registration is on a first-come, first-served basis and is subject to space limitations.  Interested participants can register to attend the meeting online at: http://www.PHE.gov/DURCworkshop

Additional information about the meeting, including the draft agenda and information about NIH security and other logistical matters is also posted on the meeting’s webpage.

For further information about the meeting, please email DURC@ostp.gov.

ASM comments regarding the DURC policy are available here:  http://www.asm.org/index.php/public-policy/137-policy/documents/statements-and-testimony/93024-durc-7-31-14.

FDA Invites ASM to Expand Duodenoscope Culture Standards
Several healthcare facilities have identified clusters of infections associated with duodenoscopes. To verify that best practices for cleaning and disinfection of these instruments are being followed, some facilities have instituted routine culture. At present, there is a lack of consensus on the utility of such testing, and the specific test methods that should be employed.  The Food and Drug Administration (FDA) reached out to ASM after the PSAB Laboratory Practices Committee produced “On Culturing of Duodeoscopes” (http://www.asm.org/index.php/public-policy-2/98-policy/issues/93456-lp-4-15) and is currently working with ASM to identify expert volunteers to assist with development of a protocol for validation of an endoscope culturing method.  To see the FDA’s most current documents on infections associated with reprocessed duodenoscopes, please go to http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/ucm436580.htm.  

ASM Joins S-FAR Webinar on S.185, the PATH Act
On May 7, ASM joined the U.S. Stakeholder Forum on Antimicrobial Resistance (S-FAR) in a webinar with staff from the offices of Senators Orrin Hatch and Michael Bennet, who introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act, S. 185.  This legislation amends the Federal Food, Drug, and Cosmetic Act to require the FDA to establish a program to approve an antibacterial drug intended to treat a serious medical condition and to address an unmet medical need within an identifiable limited population as a limited population antibacterial drug.  S-FAR was convened on the principle that U.S. government strategies to address antimicrobial resistance should involve sustained engagement with experts and stakeholders throughout the policy development and implementation process.  To read more about S-FAR, go to http://www.s-far.org/.

FDA and CMS Form Task Force on LDT Requirements
ASM staff have been monitoring the FDA “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” since it was issued in October 2014 (http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm416685.pdf ).  Under the proposed framework, FDA would oversee the quality of these tests, with the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories through the Clinical Laboratory Improvement Amendments (CLIA).  To coordinate efforts, FDA and CMS have established an interagency task force that will continue and expand collaboration related to oversight of LDTs and will be comprised of subject matter experts from each agency. Read more about it at http://blogs.fda.gov/fdavoice/index.php/2015/04/fda-and-cms-form-task-force-on-ldt-quality-requirements/

Public and Scientific Affairs Board asm2015 Special Interest Symposiums

Immunology Issues and Infection in Hemoglobinopathy Populations with Health Disparities
Sunday, May 31, 2015, 4:45 - 6:30 PM
Ernest N. Morial Convention Center, Meeting Room 346
Sponsored by the Committee on Microbiological Issues Impacting Minorities
Hemoglobinopathies are genetic blood disorders caused by mutations in the hemoglobin gene which result in abnormal function and/or production of hemoglobin. Sickle cell disease (SCD) and thalassemia are the most commonly inherited blood disorders among populations in the United States. Affected individuals other than African Americans have ethnic backgrounds rooted in Central and Southeast Asia, the Mediterranean countries, North Africa, the Middle East, and India. Numerous sickle gene polymorphisms occur in populations with health disparities. It is commonly thought that the sickle gene confers resistance to diseases such as malaria but this may not be entirely true. Populations affected with the sickle gene are exposed and susceptible to a range of pathogens in different geographical regions. At the end of this special interest session attendees will have an understanding of how host pathophysiological conditions of populations living with hemoglobinopathies are exposed to various infections. Insight on progress and policy issues to prevent infection and decrease morbidity in populations with health disparities will be discussed.

Contributions to “Extreme” Microbiology by Female Scientists
Sunday, May 31, 2015, 4:45 - 6:30 PM
Ernest N. Morial Convention Center, Meeting Room 355
Sponsored by the Committee on the Status of Women in Microbiology
Previously, the past chair of the Committee on the Status of Women in Microbiology (CSWM) highlighted the important contributions by women microbiologists to the field of microbiology in a session entitled “Microbial Exotica and the Women Who Nurture Them.” In honor of Dr. Findlay’s contributions to the CSWM, the committee is repeating this theme. The women presenting in this session will expand the environments that are considered extreme; bacterial metabolism under a variety of geochemical conditions to ancient microbial life. The concept of “extreme” microbiology will be further developed by considering working under extreme conditions, such as a BSL-4 laboratory. Overall, this session will explore what it means to participate in extreme microbiology and demonstrate that the women who participate in this area of research are truly passionate about their subject, an aspect that Dr. Findlay conveyed with her previous “Microbial Exotica and the Women Who Nurture Them” session

Making Your Presence Known
Monday, Jun 01, 2015, 4:45 - 6:30 PM
Ernest N. Morial Convention Center, Ernest N. Morial Convention Center
Sponsored by the Committee on Professional Affairs
Four key speakers will review their experiences and outline ways to further awareness of clinical microbiology. They bring years of experience with programs and outcome studies that demonstrate the critical significance of the profession in a time when lab personnel shortages, decreased reimbursement and ever changing technological advancements prevail.

Implementing IQCP in Your Laboratory
Monday, Jun 01, 2015, 4:45 - 6:30 PM
Ernest N. Morial Convention Center, Meeting Room 343
Sponsored by the Committee on Laboratory Practices
The "Individualized Quality Control Plan” (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) policy currently under development as an alternative QC option. The guidance and concepts for IQCP are a formal representation and compilation of many of the activities currently undertaken in laboratories to ensure quality test results for their patients. IQCP permits the laboratory to customize its QC plan according to test method, patient population, environment, and personnel competency. As this plan is implemented by CMS in January of 2016, members of the clinical laboratory community must be prepared for these new regulations. This session will address concerns of clinical microbiology, molecular microbiology and immunology laboratories.

A list of speakers and other asm2015 events are listed on the meeting website:  http://gm.asm.org/.

Minority Microbiology Mentor Newsletter
The May 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/93517-mmm-5-15

Committee on the Status of Women in Microbiology Communicator – Spring 2015
The Spring 2015 issue of the CSWM Communicator has been published by the CSWM.  It features highlights of the committee's activities at this year asm2015 meeting in New Orleans, LA.  You can read the newsletter by going to this link: http://www.asm.org/index.php/component/content/article/97-policy/documents/93524-cswm-spring-2015.

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