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Public and Scientific Affairs Board

Ronald Atlas

Chair, Public and Scientific Affairs Board

 

Federal Funding Advocacy

 

PSAB directed efforts to end sequestration and ensure that research and public health program funding levels are a priority in the budget process.  ASM urged members of the Budget Conference Committee to increase funding to the highest possible levels in the (FY) 2014 budget for basic life science research and public health programs at the NIH, CDC, NSF, FDA, DOE and USDA.  Congress passed a budget compromise measure that rolled back budgetary sequestration and mitigated some of the harm from the random cuts of sequestration for FY 2014 and FY 2015.  The Consolidated Appropriations of 2014 restored about two thirds of the Sequestration cuts.  PSAB will continue to advocate for robust investment in basic research as the appropriations process proceeds for FY 2015.  A summary of the Omnibus is available on the Public Affairs web site at:  http://www.asm.org/ResearchFunding.   The ASM issued a statement thanking Congress:  http://www.asm.org/index.php/public-policy-2/92-news-room/press-releases/92725-asm-statement-on-the-fy-2014-omnibus-appropriations-bill.

 

Throughout 2013, PSAB worked to inform policymakers about the damaging impact of sequestration.  Legislative alerts were sent to members asking them to communicate with policymakers about the importance of federal investment in research and public health, and the devastating impacts that sequestration would bring.  The Public Affairs web page includes budget status updates and helpful links to the ASM’s Legislative Action Center and a guide to communicating with Congress called, “Taking the Message to Congress.”  PSAB staff attended meetings at the White House and with congressional staff to discuss policy issues impacting the research community including sequestration.

 

PSAB submitted written testimony to Congress on FY 2014 appropriations for the NIH, FDA, USDA Research, DOE Biological Science, CDC, NSF, and EPA microbiology programs.  The statements were compiled into a booklet titled Federal Funding for FY 2014: Biomedical and Life Sciences Research and distributed to members of Congress and science and health staff.  

 

PSAB attended a meeting with Catherine Woteki, Under Secretary of Research, Education, and Economics (REE) and Chief Scientist, and Sonny Ramaswamy, director of the National Institute of Food and Agriculture (NIFA), to discuss current funding concerns for NIFA and the Agriculture and Food Research Initiative (AFRI), as well as ways to work with the USDA to ensure that funding success stories are relayed to policymakers. Chuck Rice, chair of the PSAB Committee on Agricultural and Food Microbiology, met with congressional staff on a number of occasions to discuss sequestration impacts and the importance of competitive grants funded by the AFRI.  PSAB met with staff of the House Committee on Agriculture to discuss the Farm Bill and highlighted the significance of Title VII (Research) funding, which invests in high priority research areas including specialty crops and bio-energy. 

 

Gail Cassell, Chair of the PSAB Committee on Biomedical Research, and Janet Shoemaker met with staff of the House Appropriations Subcommittee on Labor/Health and Human Services and Education and health and science policy staff in the offices of Representatives Jackie Speier and Lucille Roybal-Allard.  Representative Speier chairs the House Biomedical Research Caucus and Representative Roybal-Allard is a member of the House Labor/HHS appropriations. 

 

Research and Public Health Activities

 

On February 7, 2014, the PSAB met with the following policy makers: Jon R. Lorsch, Director, NIGMS, Anthony Fauci, Director, NIAID, Cora B. Marrett, Acting Director, NSF, Thomas R. Frieden, Director, CDC, Rima Khabbaz, Deputy Director for Infectious Diseases, CDC, Francis S. Collins, Director, NIH, William Flynn, Deputy Director for Science Policy, Center for Veterinary, Medicine and Sally A. Hojvat, Director, Division of Microbiology Devices, Office of In-vitro, Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA.  Topics included the NIGMS Strategic Plan, peer review and study section issues, NSF BIO issues, DURC and GOF research issues, CDC ID issues, AR issues and plans for ASM task force focus.  On February 8, 2013 PSAB met with the following policy makers, Anthony Fauci, Director, NIAID, NIH, Margaret A. Hamburg, Commissioner, FDA, Rima Khabbaz, Deputy Director for Infectious Disease, Franca R. Jones, Assistant Director, Chemical and Biological Countermeasures, National Security & International Affairs Division, OSTP and Catherine Woteki, Under Secretary for Research, Education, and Economics, Research, Education, and Economics, USDA.  The PSAB reviewed policy issues of importance to microbiology and committee activities for the coming year. 

 

ASM Meets with NIGMS Director

 

Timothy Donohue, ASM President Elect and Janet Shoemaker met with Jon R. Lorsch, Director, NIGMS and Darren Sledjeski, Program Director and Chief, Genetic Mechanisms Branch Division of Genetics & Developmental Biology to discuss microbiology research and training issues.

 

Golden Goose Award/Science Laureate Bill

 

The ASM endorsed legislation to establish a science laureate for the United States.  ASM sponsored and attended the 2013 Golden Goose Award ceremony in Washington, D.C.  Created in 2012 the award demonstrates the human and economic benefits of federally funded research by highlighting examples of seemingly obscure or silly sounding research projects that have led to major breakthroughs and resulted in significant societal impact.”

 

COMPETES Act

 

ASM signed letters supporting passage of an American COMPETES reauthorization bill which was sent to the chairs and ranking members of House and Senate committees responsible for COMPETES Act authorization.  It outlined the importance of a bill with sustained growth and funding for the NSF, NIST, DOE Office of Science, and the Advanced Research Projects Agency - Energy (ARPA-E).  

First Legislation Letter

 

ASM joined scientific organizations to send a letter to the House Science Committee stating concerns with provisions in the draft legislation entitled, “Fronties in Innovation, Research, Science and Technology, (FIRST Act) a draft bill which would change NSF peer review.

 

Administration Issues New Guidance for Government Employee Travel

 

A letter was sent in January 2014 to the Senate HSGA Committee for the hearing record supporting government science travel:  http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/92714-travel1-13-14.   Other letters were sent in 2013 to Congress to educate them about government science travel.

 

Letter in Support of NSF’s Merit Review Process

 

A coalition letter was sent to the House Committee on Science, Space, and Technology and the Senate Committee on Commerce, Science and Transportation regarding the merit review process of the NSF. The letter cautions against changing the criterion for awarding grants, highlights the importance of NSF funded research and supports the funding of basic research at NSF.   Jay Grimes, Chair of the PSAB Committee on Environmental Microbiology met with staff in the offices of Senator Roger Wicker (MS), Senator Thad Cochran (MS) and Senator Barbara Mikulski (MD) to discuss the importance of federal funding for research and development at the federal agencies, especially the NSF and the DOE.

 

ASM Meets with DOE, Office of Science Officials

 

Timothy Donohue, ASM President Elect; Ron Atlas, chair of the PSAB; Chuck Rice, chair of the PSAB Committee on Agricultural and Food Microbiology and PSAB Staff met with; Sharlene Weatherwax, Associate Director of Science for Biological and Environmental Research (BER); Todd Anderson, Director of Biological Systems Science Division (BSSD) Joe Graber, Program Manager, BSSD; and Daniel Drell, JGI Program Manager, BSSD at the DOE. The meeting focused on federal funding issues and Office of Science activities related to microbiology and ways in which the ASM could continue to collaborate with the DOE to ensure cohesive messaging and communication.  

 

Animal Research

 

In February, ASM participated in a meeting of the Washington Animal Research Network (WARN.) Discussed were activities taken by Congress and the agencies in the past year that impact the biomedical and research community including the Great Ape Protection and Cost Savings Acts.

 

ASM Holds Congressional Briefing

 

ASM held a Congressional Briefing, "The Perpetual Challenge of Infectious Diseases: New and Emerging and Antimicrobial Resistance" on April 30, 2013.  Dr. Gail H. Cassell organized and moderated the session.  Anthony S. Fauci, M.D. presented, “Infectious Diseases in the 21st Century: Challenges and Opportunities” and John I. Gallin, M.D., Director, Clinical Center and Associate Director for Clinical Research discussed, “The Role of the NIH Clinical Center in Understanding Disease Pathogenesis and Drug Discovery.”  Dr. Cassell presented a talk titled, “Global Crisis of Drug Resistant Tuberculosis: a Case Study in the Critical Role of NIH.”  The briefing was attended by congressional staffers and agency representatives.

 

ASM Meetings on Antimicrobial Resistance

 

PSAB Committee on Biomedical Research chair, Gail Cassell, and Public Affairs staff, held a number of meetings to discuss initiatives related to antimicrobial resistance.  Dr. Cassell and Ron Atlas, chair of the PSAB, met with OSTP Science Division staff to learn about the Administration’s concerns and initiatives by the President’s Council of Advisors for Science and Technology (PCAST). PSAB also had a discussion with staff at the NIAID Division of Microbiology and Infectious Disease (DMID) to review efforts in antimicrobial resistance including basic, therapeutic and clinical research activities and promising candidate products.  A meeting also took place with staff from the FDA Office of Antimicrobial Products to discuss FDA involvement and activities related to antimicrobial resistance. On the same topic a discussion occurred with staff from the CDC National Center for Emerging and Zoonotic Infectious Diseases. The PSAB is in the process of review and updating its Task Force recommendations which are available at http://www.asm.org/images/docfilename/0000005962/antibiot[1].pdf.

 

Limited Use Antibiotic Pathway Legislation Introduced

 

The Antibiotic Development to Advance Patient Treatment (ADAPT) Act was introduced on December 11. The legislation would help streamline the regulatory pathway for antibiotics that could address dangerous pathogens.

 

ASM Endorses World Alliance Against Antibiotic Resistance Declaration

 

ASM endorsed the World Alliance Against Antibiotic Resistance declaration.

 

Biodefense and Emerging Infections Activities

 

ASM Comments on Proposed HHS Funding Framework for H5N1 Research:  The PSAB sent a letter to the NIH which included concerns and recommendations related to the November 27 2012 Proposed Framework for Guiding Health and Human Services (HHS) Funding Decisions about Highly Pathogenic Avian Influenza Gain-of-Function Research. 

 

HHS Framework for H5N1 Influenza Research:  On February 21, 2013 the Department of Health and Human Services published a Framework to guide funding decisions on proposals for research anticipated to generate HPAI H5N1 viruses that are transmissible among mammals by respiratory droplets.  PSAB sent comments on the Framework. 

 

ASM Comments on RAC Biosafety Guidelines for HPAI H5N1:  On March 25, PSAB responded to the NIH’s OBA request for public comments on its February 21, 2013 Federal Register announcement regarding changes to the NIH Recombinant DNA Molecules guidelines. These guideline changes involve biosafety enhancements to facilities and equipment and occupational health practices for research with highly pathogenic avian influenza (HPAI) H5N1 viruses that transmit among mammals by respiratory droplets.  .

PSAB Attends Meeting on Select Agent Regulations:  PSAB Biodefense Committee Chair, Ronald Atlas, attend a meeting hosted by the AAAS on challenges faced in implementing the revised Select Agents and Toxins Regulations.

 

Dual Use Policy for Institutions:  ASM joined the White House OSTP as they discussed the new USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC).

 

ASM Comments on Dual Use Research Policy:  PSAB responded to a February 22, 2013 Federal Register (V0l 78 No 36) notice requesting comments on the proposed USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC). The policy establishes institutional review and oversight requirements for 7 categories of research with 15 high risk pathogens. 

 

ASM Sends Letter to Congress in Support of Bioinformatics Initiative:  PSAB sent a letter to the House and Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittees supporting the new CDC initiative “Advanced Molecular Detection and Response to Infectious Disease Outbreaks (AMD).”  The proposed FY 2014 funding for this program will allow CDC to invest in improved laboratory identification of pathogens, provide new bioinformatics capacity, and enhance disease surveillance, including the detection of emerging antibiotic resistance. 

 

Clinical Microbiology Activities

 

ASM Monitoring Clinical Lab Fee Schedule Changes:  The PSAB Professional Affairs Committee has been monitoring key developments in reimbursement for clinical laboratory tests.  Starting in 2014, CMS will propose reimbursement changes to a list of tests; they have indicated they will begin with the tests first placed on the CLFS and work their way from oldest to newest tests in five years.  Initial comments were submitted.  The PAC has also been following the CMS final rule “Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral” [CMS-1443-P]. 

   

LRN Sentinel Protocol Revision:  On January 10, members of the Committees on Laboratory Practices and Professional Affairs met with APHL volunteers and staff to make final revisions to the Laboratory Response Network (LRN) Sentinel Level Clinical Laboratory Testing Protocols. 

 

ASM Attends Coordinating Council on the Clinical Laboratory Workforce:  Vickie Baselski, chair of the PSAB Committee on Professional Affairs, represented ASM at the Coordinating Committee for the Clinical Laboratory Workforce (CCCLW) meeting in Chicago.  The March meeting focused on a number of crucial topics including:  the CCCLW stated goals, the updated guidance document, the newly updated CCCLW website and its related links, and results of the 2013 Medical Laboratory Observer annual salary survey. 

 

ASM Signs CLC Letter:  ASM joined members of the Clinical Laboratory Coalition (CLC) in a letter to Senate Finance Committee Chairman Baucus and Ranking Member Hatch opposing further reductions in Medicare Part B Clinical Laboratory Fee Schedule (CLFS) payments, as proposed in the President’s 2014 Budget.

ASM Cosponsors Medical Laboratory Professionals Week:  Since 1975, clinical laboratory organizations have been observing Medical Laboratory Professionals Week (MLPW) during the last full week in April as an annual celebration of the more than 300,000 laboratory professionals and pathologists who perform and interpret more than 10 billion laboratory tests in the US every year. 

 

ASM Attends FDA Microbiology Devices Panel Meeting:  ASM attended the meeting of the FDA Microbiology Devices Panel of the Medical Devices Advisory Committee convened to discuss regulation of rapid influenza detection tests that are currently regulated as Class I devices. 

 

ASM Makes Recommendation on New CPT Code:  The ASM presented recommendations to the CMS at its annual Clinical Laboratory Fee Schedule public meeting on July 10. 

 

ASM Signs Letter Requesting Meeting on Lab Fee Study:  The ASM joined members of the Clinical Laboratory Coalition (CLC) in a letter to request a meeting with the Office of Inspector General to discuss the findings and methodology of the June 2013 study entitled “Comparing Lab Test Payment Rates: Medicare Could Achieve Substantial Savings.”

 

PSAB Committee Prepares Cyclospora Guideline:  The PSAB Committee on Laboratory Practices prepared A Practical Guidance Document for the Detection of Cyclospora to aid laboratory personnel in their identification of this organism, since routine ova and parasite examination often fails to detect it. 

 

ASM Attends the Joint Commission Lab PTAC Meeting:  The Joint Commission’s Laboratory Professional and Technical Advisory Committee (Lab PTAC) met on August 13 with ASM and other organizations. 

 

ASM Comments on Two CMS Proposed Laboratory Payment Revisions:  ASM commented on two separate proposals from the CMS published in the Federal Register on July 19, both of which will affect clinical laboratory test reimbursement.  The second CMS proposed change, “Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, and Other Revisions to Part B for CY 2014 [Proposed Rule CMS-1600-P]” has the potential to significantly affect the laboratory’s ability to provide testing for the patients they serve.  Chief among them is to fully engage all stakeholders in this process.

 

ASM Joins the Clinical Laboratory Coalition Visit to CMS:  The Clinical Laboratory Coalition (CLC) visited the CMS to discuss the Clinical Laboratory Fee Schedule reform proposal [Proposed Rule CMS-1600-P].  

 

ASM Comments on National Coverage Analysis for Screening for Hepatitis C in Adults:  PSAB commented on the National Coverage Analysis (NCA) Tracking Sheet for Screening for Hepatitis C Virus (HCV) in Adults (CAG-00436N), supporting many of the proposals outlined in CAG-00436N to expand preventive services coverage to include screening for HCV in the groups identified in the 2013 United State Preventive Services Task Force (USPSTF) recommendations. 


 

PSAB Committee on Microbiological Issues Impacting Minorities and the Committee on the Status of Women in Microbiology Activities

 

ASM General Meeting Minority Travel Grants Awarded:  During the asm2013 General Meeting the awardees of the ASM General Meeting Minority Travel Grant were honored at a reception organized by the Committee on Microbiological Issues Impacting Minorities (CMIIM). 

 

Committee on the Status of Women in Microbiology (CSWM) asm2013 Events:  At the 2013 ASM General Meeting, the Committee on the Status of Women in Microbiology (CSWM) held a reception honoring the 2013 Roche Diagnostics Alice C. Evans Awardee, Joan Steitz, Ph.D. of Yale University, New Haven, Connecticut.  The CSWM held an Open Forum Meeting that allows attendees to discuss issues that are of importance to women microbiologists, including, breaking barriers in career advancement, balancing career and family, tenure and career advancement, salary concerns, attracting more women to the life sciences and networking.  The CSWM also sponsored a special interest session, “Men, Women, Infection, and Infertility.” The CSWM also published a spring edition of their newsletter, the CSWM Communicator.

 

ASM Selects Congressional Science Fellow for 2013 -2014:  The ASM awarded the ASM Congressional Science Fellowship to Elizabeth Stulberg for 2013 – 2014.  Elizabeth received her Ph.D. in the Department of Molecular, Cellular and Developmental Biology at Yale University. 

 

asm2014 PSAB Special Interest Sessions

 

Sunday, May 18 4:45 – 6:30 p.m.

 

  • Women Microbiologists in Developing Economies: The Obstacles and the Opportunities (Developed by the Committee on the Status of Women in Microbiology)
  • Microbial Interactions in a Changing Climate (Developed by the Committees on Environmental Microbiology and Agricultural and Food Microbiology)
  • Drug Resistance in Populations with Health Disparities (Developed by the Committee on Microbiological Issues Impacting Minorities)

 Monday, May 19 4:45 – 6:30 p.m.

 

  • Navigating the 21st Century Workplace: Key Drivers for the Laboratory Industry and Profession (Developed by the Committee on Professional Affairs)

Federal Funding Opportunities Breakfast

Monday, May 19, 8:00 – 9:00 a.m.

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