2016 Comment Letters

ADLM continually tracks legislative and regulatory issues of importance to clinical laboratories and the clinical laboratory profession. This is a listing of ADLM's 2016 comment letters. ADLM commented on a wide range of topics to federal and state authorities.

2016 Legislative and Regulatory Issues

AACC Endorses Restrictions on Agency Use of Guidance Documents

Nov.14.2016

AACC Recommends FDA Defer to CLIA Oversight of NGS Testing

OCT.6.2016

AACC Identifies for FDA Limits of Gene Variant Databases

OCT.6.2016

AACC Provides Input to Senate HELP Committee on LDT Regulatory Oversight

SEPT.19.2016

AACC and healthcare partners continue to pursue CDC harmonization funding

SEPT.12.2016

AACC Opposes VA Proposal to Extend Nurses Scope of Practice to Labs

JULY.22.2016

AACC urges CMS to use rulemaking process regarding CLIA equivalency for nursing degrees

JUNE.17.2016

Healthcare groups ioin AACC in support of federal funding for harmonization

MAY.27.2016

AACC urges the Senate to require FDA justification of guidance documents

MAY.19.2016

AACC urges Senate delay of LDT guidance

MAY.16.2016

AACC joins effort in support of additional funds to stop the Zika virus

MAY.13.2016

AACC submits comments to FDA regarding analytical validation of LC-MS

MAY.09.2016

AACC supports House language delaying FDA LDT guidance

MAY.04.2016

AACC provided testimony at FDA workshop on the regulation of Mass Spectrometry

MAY.02.2016

AACC joins the March of Dimes in support of emergency funding for CDC to prepare for Zika virus

APR.05.2016

AACC Provides FDA with feedback on reporting of genetic test results

MAR.28.2016

AACC Joins Friends of AHRQ to Support Restoration of Agency’s Funding

MAR.14.2016

Laboratory Community Urges Federal Funds for Harmonizing Test Results

FEB.26.2016

AACC joins Children's Health groups in raising concerns about OHRP changes to Common Rule

JAN.06.2016

AACC Opposes OHRP Limits on Use of Residual Specimens

JAN.05.2016