e-Public Policy Newsletter - July 2012

  • ASM Joins Coalition to Avert Cuts to Science Budgets
  • ASM Comments on FDA Guidance for Industry on Animal Drugs
  • Webinar:  A National Conversation on the Future of Agricultural Research
  • Payment Determinations for Calendar Year 2013 for New Clinical Laboratory Tests
  • ASM Meets with CDC and APHL in June CDC Campylobacter Diagnostic Meeting
  • FDA User Bill Signed into Law with Antibiotic Incentives, LDT Guidance
  • Release of the 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy
  • NIH Common Fund Announces New Programs
  • NIH Human Microbiome Project Defines Normal Bacterial Makeup of the Body
  • National Science Board Report:  Research & Development, Innovation, and the Science and Engineering Workforce
  • National Research Council Report:  Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas
  • ASM General Meeting Minority Travel Grants Awarded
  • S3 Federal Biorisk Management Policy Newsletter
  • Minority Microbiology Mentor Newsletter

ASM Joins Coalition to Avert Cuts to Science Budgets
The ASM joined with approximately 3,000 organizations to avert the sequestration or across-the-board cut to nondefense discretionary programs, including science and public health programs, required by the Budget Control Act in 2013.  A letter, delivered to Congress on July 12, asked members to adopt instead a balanced approach to deficit reduction that does not include indiscriminate cuts to nondefense discretionary programs like science and public health. In 2011 nondefense discretionary spending represented less than one-fifth of the federal budget and 4.3 percent of Gross Domestic Product (GDP). Under the discretionary caps in the bipartisan Budget Control Act of 2011, by 2021 nondefense discretionary spending will decline to 2.8 percent of GDP if sequestration takes effect. The goal of the letter is to educate Congress about the impact of indiscriminate cuts on a range of national priorities that strengthen economic growth, safety, security and public health.  To read the letter, go to:  http://publichealthfunding.org/uploads/NDDLetter.Final.July2012.pdf

ASM Comments on FDA Guidance for Industry on Animal Drugs
On July 9, the ASM Public and Scientific Affairs Board sent a letter to the FDA commenting on its draft guidance for industry that is intended to phase out the nontherapeutic use of antimicrobial drugs in food-producing animals (see Microbe Forum).  The FDA published three documents in the April 13, 2012 Federal Register, proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals. Under the initiative, certain antibiotics would not be used for production purposes, such as enhanced growth or to improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illness in food-producing animals under the supervision of a veterinarian. The ASM letter is available at http://www.asm.org/index.php/public-policy-2/97-policy/documents/7814-fda-213.

Webinar:  A National Conversation on the Future of Agricultural Research
Wednesday July 25 from 11:00 AM to 12:15 PM EDT

World hunger. Food safety. Childhood obesity. Energy. Farming Conditions. These are all pressing issues our nation is facing. How is agricultural research addressing them?  Join four of the nation's leading voices in agricultural research and food policy for a webcast to discuss the future of agricultural research in America.

Speakers:

  • William Danforth, Chancellor Emeritus of Washington University and Chair of the Board of Trustees of the Donald Danforth Plant Science Center
  • Donald Kennedy, President Emeritus of Stanford University, former Commissioner of the Food and Drug Administration, and the former editor-in-chief of Science;
  • Roger Beachy, former Chief Scientist at USDA and the first director of the agency's National Institute of Food and Agriculture;
  • Carol Tucker Foreman, Distinguished Fellow at the Consumer Federation of America's Food Policy Institute and a nationally known expert on food safety.

These leaders have created Supporters of Agricultural Research or SOAR, a new organization working to build a coalition of farm and consumer groups, universities, and scientific organizations that will encourage federal science policy to generate agriculture innovations.  SOAR's goal is to substantially increase federal support for investigator-initiated agriculture research grants.  

To register for the webinar go to:  https://events.r20.constantcontact.com/register/eventReg?llr=drajzjdab&oeidk=a07e64jb44t631dd2b5&oseq=a026pch4fowocw

Payment Determinations for Calendar Year 2013 for New Clinical Laboratory Tests
One July 6, Vickie Baselski submitted ASM’s recommendations with respect to payment determinations to the Center for Medicare & Medicaid (CMS) for select new Current Procedural Terminology (CPT) codes to be included in the 2013 Medicare Clinical Laboratory Fee Schedule.  These recommendations were based on a consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs and Committee on Laboratory Practices, which reviewed the codes to be addressed and provided input.   Of particular interest are several new multi target respiratory virus CPT codes, new codes for genotype analysis of CMV and Hepatitis B, and a new code for cell enumeration using immunologic selection and identification in fluid specimen.  The public meeting, intended to provide expert input on the nature of the new test codes and receive recommendations to either crosswalk or gap-fill for payment, was held July 16-17 in Baltimore, MD and was attended by Dr. Baselski and ASM staff member Kimberly Walker.   A summary outlining the ASM’s recommendations can be found at the following link: http://www.asm.org/index.php/public-policy-2/97-policy/documents/7818-cms-13.

ASM Meets with CDC and APHL in June CDC Campylobacter Diagnostic Meeting
ASM, the Association of Public Health Laboratories (APHL) and the Centers for Disease Control and Prevention (CDC) held a joint forum entitled “Developing Best Practice Laboratory Guidelines for Campylobacter Diagnosis” in Atlanta on June 26.  Susie Sharp, Chair, PSAB Committee on Laboratory Practices, presented findings on a survey of laboratories performing EIA or culture to detect Campylobacter and Vickie Baselski, Chair, PSAB Professional Affairs Committee, discussed practical considerations associated with productivity and payment for enhanced Campylobacter detection.  The working group, which also included Alice Weissfeld representing ASM, has begun to assign tasks to members to aid in preparation of the first draft of the guidelines.

FDA User Bill Signed into Law with Antibiotic Incentives, LDT Guidance
The FDA user bill that was signed into law in July includes provisions from the Generating Antibiotic Incentives Now (GAIN) Act. This is the first time Congress has passed legislation that includes provisions to incentivize the development of new antibiotics. GAIN was supported by public health groups, including the ASM. The congressionally passed provisions provide five years of additional FDA exclusivity for new antibiotics that treat serious and life threatening conditions, guarantee fast tract status and priority review for qualified infectious disease products and direct the FDA to develop new guidance on pathogen focused antibacterial drug development. Passage of GAIN is viewed as an important first step in refilling the antibiotic pipeline with promising new drugs to treat patients with drug-resistant infections.   A second provision prohibits the FDA from issuing draft guidance on the regulation of Laboratory Developed Tests (LDTs) without a prior 60 day notification to both the House Committee on Energy and Commerce and the Senate Health Education and Pensions Committee of their intent.  They are also required to provide the anticipated details of any such guidance. 

Release of the 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy
The 2012 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy was released in June.  This document articulates the strategic direction for federal efforts to protect the population from national health security threats through the use of medical countermeasures.  It is in alignment with the Department of Health and Human Services’ (HHS) Strategic Plan, the HHS Secretary’s Strategic Initiatives and the National Health Security Strategy.

The 2012 PHEMCE Strategy establishes the following strategic goals:

  • Goal 1:  Create, develop, manufacture, and procure critical medical countermeasures.
  • Goal 2:  Establish and communicate clear pathways to facilitate medical countermeasure development and use.
  • Goal 3:  Develop logistics and operational plans for optimized use of medical countermeasures at all levels of response.
  • Goal 4:  Address medical countermeasure gaps for all sectors of the American population.

The 2012 PHEMCE Strategy can be found online at http://www.phe.gov/phemce/strategy.

NIH Common Fund Announces New Programs
New programs exploring novel approaches to cell-to-cell communication and understanding undiagnosed diseases, which represent challenges or scientific opportunities for a wide array of health research, are the latest priorities for the National Institutes of Health Common Fund. The Common Fund targets strategic investments that have the potential for rapid and significant impact. The programs are scheduled to begin during fiscal year 2013.  The research products of Common Fund programs are expected to catalyze disease-specific research supported by the NIH Institutes and Centers. Additional information about the NIH Common Fund can be found at http://commonfund.nih.gov.

NIH Human Microbiome Project Defines Normal Bacterial Makeup of the Body
Microbes inhabit just about every part of the human body, living on the skin, in the gut, and up the nose. Sometimes they cause sickness, but most of the time, microorganisms live in harmony with their human hosts, providing vital functions essential for human survival. For the first time, a consortium of researchers organized by the National Institutes of Health has mapped the normal microbial makeup of healthy humans, producing numerous insights and even a few surprises.  The Human Microbiome Project is managed by National Human Genome Research Institute, in partnership with the NIH Office of the Director, the National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Cancer Institute, National Institute of Dental and Craniofacial Research, and National Institute of Diabetes and Digestive and Kidney Diseases, all part of NIH.  For more information, go to:  http://www.ploscollections.org/article/browseIssue.action?issue=info:doi/10.1371/issue.pcol.v01.i13.

National Science Board Report:  Research & Development, Innovation, and the Science and Engineering Workforce
The National Science Board (NSB), the policy-setting body for the National Science Foundation, issued a white paper concerning current research and development trends. The NSB said that "between 2008 and 2009, in the midst of the most recent recession, American businesses cut funding for research and development by nearly five percent, or $12 billion. The science board said these cuts coupled with government budget constraints at all levels are reasons for concern." The report did find, however, that total national R&D expenditures reached a record high of 2.9% in 2009.  To download the report go to:  http://www.nsf.gov/nsb/news/news_summ.jsp?cntn_id=124863&org=NSB&from=news

National Research Council Report:  Evaluation of a Site-Specific Risk Assessment for the Department of Homeland Security's Planned National Bio- and Agro-Defense Facility in Manhattan, Kansas
Congress requested that the U.S. Department of Homeland Security (DHS) produce a site-specific biosafety and biosecurity risk assessment (SSRA) of the proposed National Bio- and Agro-Defense Facility (NBAF) in Manhattan, Kansas. The laboratory would study dangerous foreign animal diseases -- including the highly contagious foot-and-mouth disease (FMD), which affects cattle, pigs, deer, and other cloven-hoofed animals -- and diseases deadly to humans that can be transmitted between animals and people. Congress also asked the Research Council to review the validity and adequacy of the document. Until these studies are complete, Congress has withheld funds to build the NBAF.  To read the report go to:  http://www.nap.edu/catalog.php?record_id=13031.

ASM General Meeting Minority Travel Grants Awarded
During the asm2012 General Meeting in San Francisco, CA the awardees of the ASM General Meeting Minority Travel Grant were honored at the Education Board’s annual reception.  The ASM General Meeting Minority Travel Grant program offers travel grants to increase the participation of underrepresented minority (URM) groups in the ASM General Meeting. The following outstanding 2012 awardees were introduced at the ASM General Meeting:

Faculty Awardees

Jesse Dillon, Ph.D., California State University, Long Beach
Michele K. Nishiguchi, Ph.D., New Mexico State University
Teshome Yehualaeshet, Ph.D., Tuskegee University

Postdoctoral Awardees

Zomary Flores-Cruz, Ph.D., University of Georgia
Elise A. Lamont, Ph.D., University of Minnesota

The Committee on Microbiological Issues Impacting Minorities (CMIIM) chair, Dr. Marian Johnson-Thompson presented the awards. The CMIIM developed the grant program for ASM. 

The ASM General Meeting Minority Travel Grant program selects post-doctoral scholars from underrepresented minority groups in the microbiological sciences or faculty from Minority Serving Institutions. Each grantee is offered up to $2000 to defray expenses associated with travel to the ASM General Meeting.  The grants are supported by the National Institutes of Allergy and Infectious Diseases of the National Institutes of Health.  For more information about the grant program contact ASMGMTravelGrant@asmusa.org.  The deadline for submission to apply for a grant to attend the asm2013 Meeting in Denver, CO is January 25, 2013. 

If you have colleagues or post doctoral members of your department who you think are eligible for the award, please let them know about the program.  The CMIIM would like to encourage as many applications as possible. For more information go to the ASM web page:  http://www.asm.org/asmgmminoritytravelgrant.  

S3 Federal Biorisk Management Policy Newsletter
The May issue of the Science, Safety, Security Quarterly newsletter has been published by the Division of Biosafety and Biosecurity, Office of Policy and Planning, U.S. Department of Health and Human Services.  This newsletter communicates Federal efforts in biorisk management in support of a broad initiative to optimize coordination and stakeholder outreach on biorisk management.  The S3 website, found at http://phe.gov/s3 is our major effort to compile, clarify, and improve communication on Federal biosafety and biosecurity policies.  The newsletter is available at:  http://phe.gov/s3/Documents/s3newsletter-may2012.pdf.

Minority Microbiology Mentor Newsletter
The July 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/public-policy-2/135-policy/documents/newsletters/minority-microbiology-mentor-newsletter/7851-mmm-7-12.

TPL_asm2013_SEARCH