2011 Statements and Testimony

December 13, 2011 - ASM Comments on Bioeconomy Blueprint Request for Information
The ASM sent comments to the Office of Science and Technology Policy responding to a request for information on developing a bioeconomy blueprint.

December 1, 2011 - ASM Comments on Proposed Changes to the CDC List of Biological Agents and Toxins
The ASM sent comments to the Department of Health and Human Services (DHHS) on the October 3 Notice of Proposed Rulemaking which requested input on the proposed changes to the DHHS list of biological agents and toxins that have potential as severe threats to public health and safety.

December 1, 2011 - ASM Comments on Proposed Changes to the APHIS List of Biological Agents and Toxins
The ASM sent comments to the Animal and Plant Health Inspection Service (APHIS) on the October 3 Notice of Proposed Rulemaking which requested input on the proposed changes to the USDA list of biological agents and toxins that have potential as severe threats to public health and safety.

November 15, 2011 - ASM Comments on CLIA Program and HIPAA Privacy Rule
ASM provided comments to CMS, CDC, and OCR on the proposed rule “CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports.”  ASM supports the HHS proposed federal regulatory changes that will allow patients the right to obtain laboratory data from CLIA-certified diagnostic laboratories as part of their healthcare information. 

October 27, 2011 - ASM Comments on OHRP Human Subjects Research Protection Proposed Rulemaking
ASM commented on specific aspects of the Advance Notice of Proposed Rulemaking for 45 CFR Parts 46, 160, 164 and 21 CFR Parts 50 and 56 “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators”.  In particular, the proposed additional regulatory requirements for informed consent for “spent” biological specimens to be used in research are troubling.  These specimens provide an essential, low cost source of material for procedure evaluation and would otherwise be discarded.  Additionally, it would place an undue administrative and financial burden on laboratories to obtain this consent, especially since it offers no advantage to patient protection in a clinical laboratory already operating under HIPAA privacy regulations.       

October 5, 2011 - ASM Comments on NIH RFI on Biomedical Research Training
The ASM submitted comments to the National Institutes of Health on the RFI NOT-OD-11-106: Input into the Deliberations of the Advisory Committee to the NIH Director Working Group on the Future Biomedical Research Workforce.

September 21, 2011 – ASM Letter to Joint Select Committee on Deficit Reduction
ASM sent a letter to the Joint Select Committee on Deficit Reduction about strengthening funding for science and public health programs.

August 22, 2011 - ASM Comments on FDA Draft Guidance on RUO/IUO In Vitro Diagnostics
The ASM submitted comments to the Food and Drug Administration (FDA) on the June 1, 2011 Federal Register Notice of Draft Guidance entitled “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.”

July 19, 2011 - ASM Sends Letter to Congress Regarding Medicare Part B Clinical Laboratory Services
The ASM sent letters to Senators Reid, Kyl, Baucus and McConnell and Representatives Boehner, Pelosi and Clyburn regarding the proposed implementation of Medicare Part B coinsurance on clinical laboratory services as part of the debt ceiling negotiations.

July 19, 2011 - Payment Determinations for Calendar Year 2012 for New Clinical Microbiology Tests
On July 19, Vickie Baselski, Chair of the Professional Affairs Committee, presented recommendations to the Centers for Medicare & Medicaid Services (CMS) on new laboratory codes which will be included in the 2012 Medicare Clinical Laboratory Fee Schedule.

July 19, 2011 - ASM Signs Petition Regarding STEM Research and Education
Nearly 2,800 students pursuing a Ph.D., Master’s, or bachelor’s degree in science, technology, engineering, or mathematics (STEM) have signed a letter to federal lawmakers encouraging sustained investments in the nation’s scientific research, education, and training programs

July 1, 2011 - ASM Comments on the GAIN Act
ASM sent a letter commenting on the Generating Antibiotic Incentives Now (GAIN) Act (HR 2182).

June 30, 2011 - ASM Presented Comments on the Reclassification of Molecular Diagnostics for the Rapid Detection of Mycobacterium tuberculosis Complex
The FDA Microbiological Devices Panel of the Medical Devices Advisory Committee met on Wednesday, June 29, 2011 to discuss re-classification of M. tuberculosis rapid diagnostics for detection of M. tuberculosis, and rifampin- and isoniazide-resistant M. tuberculosis.  Dr. Melissa Miller, a member of the Committee on Laboratory Practices, addressed the panel on behalf of ASM.

May 31, 2011 - ASM Letter Supporting Office of Government Ethics Rule Change
The ASM sent comments to the Office of Government Ethics supporting the proposed rule which would permit government employees to serve in their official capacity in the governance of nonprofit organizations.

April 15, 2011 - ASM Comments on Public Health Action Plan to Combat Antimicrobial Resistance
The ASM submitted comments to the Centers for Disease Control and Prevention on the draft Public Health Action Plan to Combat Antimicrobial Resistance.

April 15, 2011 - Food and Drug Administration - FY 2012 Testimony
Appropriation statement regarding FDA funding for FY 2012.

April 15, 2011 - U.S. Department of Agriculture - FY 2012 Testimony
Appropriation statement regarding USDA funding for FY 2012.

April 8, 2011 - Department of Energy - FY 2012 Testimony
Appropriation statement regarding DOE funding for FY 2012.

April 7, 2011 - National Institutes of Health - FY 2012 Testimony
Appropriation statement regarding NIH funding for FY 2012

April 7, 2011 - Centers for Disease Control and Prevention - FY 2012 Testimony
Appropriation statement regarding CDC funding for FY 2012

March 29, 2011 - Environmental Protection Agency - FY 2012 Testimony
Appropriation statement regarding EPA funding for FY 2012

March 28, 2011 - ASM Comments on Screening for Sexually Transmitted Infections (STIs)
The ASM sent comments to the Center for Medicare and Medicaid Services (CMS) regarding National Coverage Analysis on Sexually Transmitted Infections (STIs) and High-Intensity Behavioral Counseling (HIBC).

March 14, 2011 - National Science Foundation - FY 2012 Testimony
Appropriations statement regarding NSF funding for FY 2012.

February 25, 2011 - ASM Sent a Letter to Congress Concerning the FY 2011 Continuing Resolution
The ASM sent a letter to all members of Congress concerning cuts to public health and science programs in the FY 2011 Continuing Resolution.

February 15, 2011 - ASM Endorses National Groundwater Monitoring Network Support
The ASM approved the endorsement of a coalition letter supporting FY 2012 funding for a national groundwater monitoring network. The letter was sent to House and Senate Interior, Environment and Related Agencies subcommittee members and urged Congress to support $10 to $50 million of additional funding in the FY 2012 US Geological Survey Ground Water Resources Program.

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