Office of Biotechnology Activities    National Institutes of Health - Office of Science Policy   SACGHS October 22, 2003 - Presentation Materials Second Meeting - Day One Washington, DC Opening Remarks     Edward R.B. McCabe, M.D., Ph.D. SACGHS Chair     Webcast Transcript     Oversight of Genetic Technologies, Marketing, and Laboratories and the Role of Pharmacogenetic Tests in Therapeutics       Oversight of Genetic Testing Laboratories Through the Clinical Laboratory Improvement Amendments (CLIA)     Judith A. Yost, M.A., M.T. Director, Division of Laboratories and Acute Care Centers for Medicare & Medicaid Services     Slides Webcast Transcript       Plans for Augmenting CLIA to Specifically Address Genetic Testing Laboratory Issues and Concerns     D. Joe Boone, Ph.D. Associate Director for Science, Division of Laboratory Systems Public Health Practice Program Office Centers for Disease Control and Prevention     Slides Webcast Transcript       Roundtable Discussion     Facilitator: Dr. Winn-Deen     Webcast Transcript       Impact of Pharmacogenomics on Prescription Drug Labeling     Lawrence J. Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and Research Food and Drug Administration     Slides Webcast Transcript       FDA's Current Approach to the Review, Labeling and Marketing of Genetic Tests     Steven I. Gutman, M.D. Director, Office of In Vitro Diagnostics Center for Devices and Radiological Health     Slides Webcast Transcript       FDA's Future Plans to Enhance Oversight of High Risk Genetic Tests     David W. Feigal, Jr., M.D., M.P.H. Director, Center for Devices and Radiological Health Food and Drug Administration     Slides Webcast Transcript       Roundtable Discussion     Facilitator: Dr. Leonard     Webcast Transcript       FTC's Regulation of the Advertising and Promotion of Consumer Products and Its Application to Genetic Technologies     Matthew Daynard, J.D. Senior Attorney, Advertising Practices Division Bureau of Consumer Protection Federal Trade Commission     Slides Webcast Transcript       Roundtable Discussion Regarding FDA and FTC Regulation of Advertising and Promotion of Genetic Technologies     Facilitator: Ms. Zellmer     Webcast Transcript     Public Comment Session     Webcast Transcript     Continued Discussion of Oversight and Pharmacogenetics     Webcast Transcript     Genetic Discrimination in Health Insurance and Employment       Update on the Status of Federal Legislation to Prohibit Genetic Discrimination Report from the U.S. House of Representatives     Ms. Kristin Fitzgerald Professional Staff Member U.S. House Committee on Education and the Workforce     Webcast Transcript       Roundtable Discussion     Facilitator: Ms. Berry     Transcript     Top of Page

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