November 19, 2015 - ASM Comments on Proposed Changes to Human Subject Protection Regulations (Common Rule)
ASM applauds proposed changes in the Human Subject Protection Regulations that would exclude the use of spent, de-identified human specimens for routine validation of diagnostic tests, as well as other quality assurance activities and asks that that this exclusion from oversight be expanded to include all research on de-identified specimens that do not involve analysis of human genetic material.
The ASM sent funding recommendations to the Committees on Appropriations for the FDA FY 2016 budget.
The ASM sent a letter to Sylvia Mathews Burwell, Secretary of Health and Human Services, Department of Health and Human Services regarding CDC Biosafety recommendations.
October 6, 2015 - ASM Letter in Response to the Antimicrobial Resistance Rapid Point of Care Diagnostic Test Challenge
The Department of Health and Human Services (HHS) is holding a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and invited public comments regarding the technical criteria and performance characteristics of the diagnostics for which the prize will be offered. The development and use of rapid, point-of-care, and innovative diagnostic tests for identification and characterization of resistant bacteria was a goal identified in the National Strategy for Combating Antibiotic-Resistant Bacteria released in September 2014 and addressed in the National Action Plan for Combating Antibiotic-Resistant Bacteria released in March 2015.The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are contributing technical and regulatory expertise to develop the award evaluation process.
The ASM submitted FY 2016 appropriations recommendations to the House and Senate Appropriations Committees.
The ASM sent a letter to Turing Pharmaceuticals regarding the company’s recent 5,000 percent cost increase for the decades old generic drug pyrimethamine (Daraprim).
The ASM sent a letter to Representatives Boustany and Thompson regarding their proposed Antibiotic and Rapid Diagnostic Research and Development Tax Credit Act of 2015. The legislation is designed to accelerate discovery of novel tools against drug resistant microbial pathogens.
The ASM submitted questions to the Administrator of the Centers for Medicare and Medicaid Services (CMS) on the implementation of Individualized Quality Control Plans (IQCPs) in the clinical microbiology laboratory. The answers sought will allow ASM to assist clinical microbiologists prepare for implementation of their own IQCPs by the deadline of January 2016.
The ASM submitted comments to the Centers for Disease Control and Prevention on the possession, use, and transfer of select agents and toxins. The comments addressed adding certain Influenza virus strains to the List of Select Agents and Toxins.
The ASM submitted comments to the National Institutes of Health (NIH) RFI on the Framework for the NIH-wide Strategic Plan. The comments will help NIH develop a 5-year strategic plan to outline a vision for biomedical research that will pursue fundamental knowledge about the nature and behavior of living systems and apply that knowledge to extend healthy life and reduce illness and disability.
August 17, 2015 - ASM Comments on Department of State and Commerce Control Regulations for Certain Pathogens
The ASM submitted comments to the US Department of Commerce and the US State Department regarding the Category XIV materials (Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment) included on the United States Munitions List and the Commerce Control List.
The ASM presented recommendations to the Centers for Medicare & Medicaid Services at its annual public meeting on payment levels for new tests to be included in the 2016 Clinical Laboratory Fee Schedule.
January 28, 2015 - ASM Statement on the President’s Proposed 2016 Budget to Combat Antibiotic-Resistant Bacteria
The ASM released a statement on the President’s Proposed 2016 Budget to Combat Antibiotic-Resistant Bacteria.
The ASM sent comments on the 21st Centurey Cures Initiative to the House Committee on Energy and Commerce.
The ASM sent a letter to Senator Richard Durbin (D-IL) endorsing the bill which would provide a five percent increase in funding for biomedical research supported by the National Institutes of Health and other federal agencies involved in biomedical research.
April 21, 2015 - Energy & Environment Provisions in the America COMPETES Reauthorization Act of 2016
The ASM sent a letter to members of the House Committee on Science, Space and Technology about provisions in the America Competes Reauthorization Act of 2016, H.R. 1806.
The ASM submitted comments in response to the Office of Science and Technology and Policy's request for comment on the impact that the Select Agent Regulations have had on science, technology, and national security, and on the benefits, costs, and limitations of the regulations.
During the FDA Public Workshop “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” held on January 8-9, the ASM and the Pan American Society for Clinical Virology (PASCV) have commented on the implementation of this plan in clinical laboratories.
The ASM submitted comments to the Centers for Disease Control on the Biennial Review of the Select Agent Regulations.