e-Public Policy Update - February 2015

Contents:

  • President’s FY 2016 Budget Released
  • ASM Applauds FY 2016 Budget’s Increased Funding to Fight Antibiotic Resistance
  • ASM President Attends White House Briefings on Precision Medicine Initiative and the Microbiome
  • ASM Endorses American Cures Act of 2015
  • ASM Endorses the Promise for Antibiotics and Therapeutics for Health (PATH) Act
  • ASM Endorses Letter Opposing Sequestration
  • ASM Comments on FDA Oversight of LDTs 
  • General Meeting Clinical Laboratory Session Will Focus on New Quality Control Plans
  • ASM Attends CLSI Committee Week
  • House Energy and Commerce Committee Holds Hearing on the Response to Seasonal Influenza
  • ASM Congressional Science Fellow Secures Congressional Office Position
  • ASM Participates in CDC Measles Briefing
  • Minority Microbiology Mentor Newsletter
  • NIH’s Dual Use Research of Concern (DURC) Expectations for Institution

President’s FY 2016 Budget Released
On February 2, President Obama released the Administration’s fiscal year (FY 2016 budget request to Congress.  Highlights that impact the ASM membership and microbiology include:

National Institutes of Health (NIH)

  • $31.3 billion, a 3.3 percent or $1 billion increase over FY 2015. Including $100  million for antimicrobial resistance; $200 million for the new precision medicine initiative; the number of competing grants is estimated to increase by 1200 and the estimated success rate would be 19.3 percent.

Centers for Disease Control and Prevention (CDC)

  • CDC program level request is $7 billion, an increase of  $110 million over FY 2015
  • The budget includes an additional $264.3 million for the Combatting Antibiotic Resistant Initiative
  • Emerging and Zoonotic infectious diseases would increase from $405 million to $699 million, a $294 million increase; includes an increase of $10 million for laboratory capacity and safety and $10 million for enhancing laboratory training, capacity and oversight.
  • $571 million for the Strategic National Stockpile a $37 million increase above FY 2015; a $10 million increase for the Select Agent program to increase inspections by 25 percent, including surprise inspections for high risk facilities

Food and Drug Administration (FDA)

  • Total FDA funding is $4.9 billion, a 9  percent or $425 million increase over FY 2015, and includes $2.2 billion, a 15 percent or $277 million increase in user fees
  • $1.5 billion for food and feed safety a $301 million increase over FY 2015 that includes a $5.8 million reduction of “lower priority programs” in food safety
  • The budget includes a request for “broad reorganization authority” to consolidate the USDA’s Food Safety Inspection Service (FSIS) with its counterparts at the FDA into a single new agency housed within HHS.

National Science Foundation (NSF)

  • $7.7 billion a 5 percent, $379 million increase over FY 2015, including $6.1 billion for research and related activities, a 4 percent increase over FY 2015.
  • The Directorate for Biological Sciences (BIO) would receive $748 million, a 2 percent or roughly $17 million increase over FY 2015.
  • National Ecological Observatory Network (NEON) would receive just over $44 million, a 16 percent increase over FY 2015

Department of Agriculture (USDA)

  • $450 million for the Agriculture and Food Research Initiative (AFRI), a $125 million increase over  FY 2015, including $28 million to “develop, refine, and disseminate science-based knowledge about animal health management and production practices that can reduce the threat of antimicrobial resistance.” 
  • $17 million increase for ARS to “seek answers to key questions related to antimicrobial resistance in the relationships among microbes and livestock, the environment, and human health.”

Department of Energy (DOE) Office of Science

  • $5.3 billion for the Office of Science (SC), $272 million above the FY 2015 enacted level
  • $1.9 billion for basic energy sciences, or $116 million above FY 2015 and $612 million for biological and environmental research, a $20 million increase from FY 2015

For additional information and updates on the FY 2016 budget process, please visit the ASM Public Affairs webpage at: http://www.asm.org/ResearchFunding

ASM Applauds FY 2016 Budget’s Increased Funding to Fight Antibiotic Resistance
The ASM issued a statement of support for the Administration’s January 27 announcement that its FY 2016 budget would increase funding for provisions that combat and prevent antibiotic resistance in among microbial pathogens.  You can find the full statement of support at http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93355-ar-2015.

ASM President Attends White House Briefings on Precision Medicine Initiative and the Microbiome
On January 30, The White House held an event in the East Room rolling out the Precision Medicine Initiative, which was attended by ASM President Timothy Donohue.  You can see an explanation of the initiative by Associate Director for Science at the Office of Science and Technology Policy and former ASM President Jo Handelsman here: http://www.whitehouse.gov/blog/2015/01/30/precision-medicine-initiative-data-driven-treatments-unique-your-own-body.  

On December 18, Dr. Timothy Donohue, ASM President attended the Microbiome Roundtable at the White House.  The goal of the meeting was to gather microbiome experts to share individual views and identify research areas and approaches that can inform strategies for developing a roadmap for accelerating discovery within the field.  The following crosscutting questions were addressed at the roundtable, 1. What might facilitate future microbiome-related breakthroughs? 2. What game-changing applications are on the horizon? 3. What techniques best engage diverse communities that may benefit from idea sharing?

ASM Endorses American Cures Act of 2015
ASM endorsed the American Cures Act, which would provide a five percent increase in funding for research supported by the National Institutes of Health and other federal agencies.  To see the endorsement, go to http://www.asm.org/index.php/public-policy-2/137-policy/documents/statements-and-testimony/93354-ac-act-2015.  

ASM Endorses the Promise for Antibiotics and Therapeutics for Health (PATH) Act
The ASM signed on to a letter endorsing S. 185, the Promise for Antibiotics and Therapeutics for Health (PATH) Act.  The legislation would establish a new limited population antibacterial drug approval pathway for antibiotics to treat serious or life-threatening infections. To read the letter go to:  http://www.asm.org/images/PSAB/ASM-PATH-Act.pdf.

ASM Endorses Letter Opposing Sequestration
In February, ASM signed onto a letter opposing sequestration.  Sequestration is possible again as the temporary and partial relief that Chairman Ryan and Chairman Murray negotiated in the Bipartisan Budget Act expires at the end of FY 2015. With the very real threat of the return of these cuts in the upcoming FY 2016 budget cycle absent congressional action, the ASM joined other organizations to unite again to protect funding for federal programs that keep Americans safe, healthy, and secure.  The letter supports increasing funding to nondefense discretionary (NDD) programs and highlights the importance of these programs.

ASM Comments on FDA Oversight of LDTs
ASM staff attended the Food and Drug Administration (FDA) public workshop “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” on January 8-9.  The purpose of this workshop was to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostics referred to as laboratory developed tests (LDTs).  This meeting provided an additional opportunity for public discussion, which was spirited and raised many concerns from members of the clinical laboratory community. To see the agenda and list of speakers, please go to http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm423537.htm.   FDA also provided a 120-day period, beginning in October 2014 for interested parties to comment on the framework.  You can see the ASM comments, issued jointly with the Pan American Society for Clinical Virology (PASCV), by going to http://www.asm.org/index.php/publicpolicy-2/statements-testimony/137-policy/documents/statements-and-testimony/93344-ldt-2015.

General Meeting Clinical Laboratory Session Will Focus on New Quality Control Plans
In anticipation of the upcoming changes from the Centers for Medicare and Medicaid Services (CMS) Individualized Quality Control Plan (IQCP) program, the PSAB Committee on Laboratory Practices has planned a special interest session explaining these new CMS regulations.  The new plan will take effect January 2016 and will have major impact on laboratory testing, most notably, in the clinical microbiology laboratory where this will replace Equivalent Quality Control (EQC) which is now commonly used.  To read more about this program, go to the CMS Clinical Laboratory Improvement Amendments (CLIA) page on IQCP here http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html.  

ASM Attends CLSI Committee Week
PSAB Laboratory Practices Committee Chair Susan Sharp attended the Clinical and Laboratory Standards Institute (CLSI) January 8-13 Committee Week in Ft. Lauderdale, FL as an advisor to the CLSI Subcommittee on Antimicrobial Susceptibility Testing (AST). The goal of the AST is to provide useful information to enable laboratories to assist the clinician in selecting appropriate antimicrobial therapy for the best patient care.  Laboratory Practice Committee members Melissa Miller and Audrey Schuetz are also advisors to the AST.  You can follow the AST and their activities by going to http://clsi.org/standards/micro/sub-ast/.    

House Energy and Commerce Committee Holds Hearing on the Response to Seasonal Influenza
On February 2, the Subcommittee on Oversight and Investigations held hearing reviewing the preparedness and treatment efforts surrounding this year’s flu and exploring ways to improve the overall effectiveness of vaccines and anti-viral drugs. In the midst of this year’s severe flu season, members of the subcommittee examined the relationship between seasonal flu preparedness efforts and our nation’s overall pandemic readiness and response capabilities. Representatives from the Centers for Disease Control and Prevention, Food and Drug Administration, Department of Health and Human Services, and National Institutes of Health will testify. For more information and to download the testimony from the hearing go to:  http://energycommerce.house.gov/hearing/examining-us-public-health-response-seasonal-influenza.

ASM Congressional Science Fellow Secures Congressional Office Position
Clayton E. Cox, Ph.D., ASM’s 2014-2015 Congressional Science Fellow has found a placement in the office of Representative Louise Slaughter (D-NY).  Cox will be working on antibiotics in agriculture, genetics and public health issues.  The American Society for Microbiology has supported Congressional Fellows since 1977.  The ASM Congressional Science Fellowship Selection Committee selects a postdoctoral to mid-career microbiologist to spend one year on the staff of an individual congressman, congressional committee, or with some other appropriate organizational unit of Congress.   Prospective Fellows must be citizens of the United States, members of ASM for at least one year and must have completed their Ph.D. by the time the fellowship begins in September.  The Congressional Science Fellowship is supported in part by the Frobisher Fund, a bequest made to ASM by Martin Frobisher.   Contact the Office of Public Affairs at publicaffairs@asmusa.org for more information on the ASM fellowship or go to the ASM web page for a program description:  http://asm.org/index.php?option=com_content&view=article&id=7535.

ASM Participates in CDC Measles Briefing
On January 29, ASM staff participated in the Centers for Disease Control and Prevention (CDC) telebriefing providing information on current U.S. measles outbreak and guidance for health protection.  Anne Schuchat, Assistant Surgeon General, United States Public Health Service; Director, CDC’s National Center for Immunization and Respiratory Diseases discussed both imported and  Disneyland-associated cases.  To read the transcript, go to http://www.cdc.gov/media/releases/2015/t0129-measles-in-us.html.

Minority Microbiology Mentor Newsletter
The January 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/public-policy-2/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/93347-mmm-1-2015.

NIH’s Dual Use Research of Concern (DURC) Expectations for Institution
On January 26, 2015, the NIH released the deadline of September 24, 2015 for establishing the necessary infrastructure to come into compliance with the federal Policy on Dual Use Research of Concern (DURC), including establishing a standing Institutional Review Entity (IRE). Starting on that date, an IRE must assess research conducted by the institution, identify DURC as described in the Policy, and assess the benefits and risks. If an IRE determines that NIH-funded research has DURC potential, the institution must notify the grants management official or contracting officer listed on the award within 30 days. Additionally, institutions and investigators will work with NIH to develop an appropriate risk mitigation plan to guide the conduct and communication of research determined to be DURC. For more information go to the Dual Use Research of Concern web page at:  http://www.phe.gov/s3/dualuse/Pages/default.aspx.

 

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