Friday, 19 January 2018 12:47

Clinical Microbiology Issues Update - January 2018

ASM Policy 

  • ASM Supports the NIH Decision to Resume Funding on Gain-of-Function Research
  • ASM Joins Science Community Statement on Science-Based Decision-Making and Policy
  • ASM Supports Evidence-Based Science to Inform Policy
  • ASM Urges Increased Funding for AMR Programs
  • ASM Urges Increased Funding for CDC
  • December Minority Microbiology Mentor Newsletter

 ASM Resources 

  • Clinical Bench Scientists Share the Benefits of Attending ASM Microbe

 Federal News  

  • Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) Meeting
  • Screening for Hepatitis C Virus Infection in Adolescents and Adults
  • Screening Asymptomatic Bacteriuria in Adults

 FDA  

  • 21st Century Cures Act: Establishment of the Susceptibility Test Interpretive Criteria Website
  • Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry

 CDC  

  • Invitation to Manufacturers of Pertussis Serological Kits
  • CDC Investigating Multistate Outbreak of E. coli O157:H7 Infections
  • NHANES Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples  

NIH 

  • Gene-Based Zika Vaccine Developed by NIH Scientists Shows Promise in Phase 1 Testing

Other News


ASM Policy
ASM Supports the NIH Decision to Resume Funding on Gain-of-Function Research
The ASM is in support of the National Institutes of Health lifting the funding pause on gain-of-function (GoF) experiments involving respiratory viruses.  ASM also applauds the review framework released by the Department of Health and Human Services.

ASM Joins Science Community Statement on Science-Based Decision-Making and Policy
The ASM expressed concerns to Mick Mulvaney, the Director Office of Management and Budget (OMB) and requested he encourage the heads of all federal agencies to support the use of science in decision making and to support the scientists who produce the knowledge upon which the nation’s economy relies.

ASM Supports Evidence-Based Science to Inform Policy
The ASM supports the leadership and the scientists at the Centers for Disease Control and Prevention and in all federal agencies in using evidence-based science to inform budget and policy decisions surrounding prevention and defending the country from public health threats.

ASM members wishing to relay their views on this and other relevant scientific issues and advocate for microbial sciences can contact their legislators directly through the advocacy page on ASM’s website.

ASM Urges Increased Funding for AMR Programs
The ASM joined a group of organizations representing health care providers, scientists, patients, public health, and industry, to urge Congressional appropriators to increase funding for antimicrobial resistance programs and reject deep cuts proposed in the president’s budget request for Fiscal Year 2018.

ASM Urges Increased Funding for CDC
ASM joined 153 members of the CDC Coalition and other supporting state and national organizations to urge Senate and House Appropriators to provide at least $7.8 billion for the Centers for Disease Control and Prevention’s programs as they work to develop a final FY 2018 Labor, Health and Human Services, Education and Related Agencies Appropriations bill or other final FY 2018 funding legislation.

December Minority Microbiology Mentor Newsletter
The December issue of the Minority Microbiology Mentor has been published by the Committee on Microbiological Issues Impacting Minorities (CMIIM). 

 

ASM Resources
Clinical Bench Scientists Share the Benefits of Attending ASM Microbe
In May 2017, young clinical laboratory scientists were recognized for their enthusiasm and commitment to the clinical microbiology profession and awarded professional development grants to help facilitate their attendance to ASM Microbe 2017. The New Tech Professional Development Grant Program provides an opportunity for awardees to interact with pre-assigned mentors, attend symposia, visit poster sessions, network with fellow bench scientists and mentors, peruse industry-sponsored exhibits featuring the latest technological advances, and learn more about the profession of microbiology.

 

Federal News
Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) Meeting
The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) provides advice, information, and recommendations to the Secretary of Health and Human Services regarding programs and policies intended to support and evaluate the implementation of U.S. government activities related to combating antibiotic-resistant bacteria.  The next meeting of the PACCARB will be held on January 24, 2018 and can be streamed.

Screening for Hepatitis C Virus Infection in Adolescents and Adults
The U.S. Preventive Services Task Force (USPSTF) posted a final research plan on screening for hepatitis C virus infection in adolescents and adults. Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

Screening Asymptomatic Bacteriuria in Adults
The U.S. Preventive Services Task Force (USPSTF) posted a final research plan on Asymptomatic Bacteriuria testing in adults.  The final Research Plan will be used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

 

FDA
21st Century Cures Act: Establishment of the Susceptibility Test Interpretive Criteria Website
The FDA is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act.  The website can be found here. 

Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry
Several changes have been made to update the “Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,” dated May 2010, including recommendations for reentry of donors deferred because of reactive HCV test results. 

 

CDC
Invitation to Manufacturers of Pertussis Serological Kits
The Centers for Disease Control and Prevention announces an opportunity for commercial manufacturers to work with its National Center for Immunization and Respiratory Diseases (NCIRD) on the validation of pertussis serological kits prior to submission to the FDA for marketing authorization. CDC is interested in the development of an assay that is an Immunoglobulin G (IgG) anti-pertussis toxin (PT) enzyme-linked immunosorbent assay (ELISA), calibrated to an international reference standard. The ELISA will be used for in vitro serological diagnosis of pertussis in clinical cases of selected age groups. CDC will be able to provide guidance, materials, and evaluation support for the manufacturer; however, the manufacturer will be responsible for submitting a premarket submission to FDA with adequate information, including any analytical or clinical data needed to support the submission, to demonstrate that FDA can grant marketing authorization to the product. CDC is accepting information through June 18, 2018.

CDC Investigating Multistate Outbreak of E. coli O157:H7 Infections
CDC, several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Shiga toxin-producing E. coli O157:H7 infections (STEC O157:H7) in 13 states (CA, CT, IL, IN, MI, NE, NH, NY, OH, PA, VA, VT and WA). 

NHANES Stored Biologic Samples; Proposed Cost Schedule and Guidelines for Proposals to Use Serum, Plasma, and Urine Samples  
The CDC announces the availability of stored sera, plasma, and urine samples obtained from participants in the National Health and Nutrition Examination Survey (NHANES) and the fee schedule for the use of these samples. The NHANES is one of a series of health related surveys conducted by CDC’s National Center for Health Statistics (NCHS). The stored NHANES biologic samples were available December 11, 2017.

 

NIH
Gene-Based Zika Vaccine Developed by NIH Scientists Shows Promise in Phase 1 Testing
Results from two Phase 1 clinical trials show an experimental Zika vaccine, developed by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), is safe and immunogenic in healthy adults. To see NIAID Director Anthony Fauci’s latest work Pandemic Zika: A Formidable Challenge to Medicine and Public Health, click here.

 

Other News
On December 11, 2017, ACLA filed a lawsuit challenging the failure of the Acting Secretary of the Department of Health and Human Services (HHS) to comply with the data reporting requirements of Section 216 of the Protecting Access to Medicare Act (PAMA), and the unlawful exemption of the vast majority of laboratories from the requirement to report private payor data to the Centers for Medicare & Medicaid Services (CMS).  You can see the filing here. ACLA is represented by an attorney who was formerly the Deputy Associate General Counsel for Litigation, CMS division of HHS.  The filing challenges the data collected prior to the Secretary’s setting of the final rates because Congress intended for “all sectors of the laboratory market [to] be represented in the reporting system, including independent laboratories and hospital outreach laboratories…” ASM joined ACLA as well as most of the other major clinical laboratory societies in an October 2017  letter, requesting that CMS engage in a constructive dialogue with stakeholders on ways to improve the PAMA data process.  Advocacy on this issue will continue in 2018.

Last modified on Friday, 19 January 2018 13:02

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