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Roger D. Klein, MD JD

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Public Comments to Federal Agencies

Secretary’s Advisory Committee on Genetics, Health and Society, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services, Draft Report, December 2007

Secretary’s Advisory Committee on Genetics, Health and Society: Gene Patents and Licensing Practices and Patient Access to Genetic Tests, Draft Report, March 2009

Agency for Healthcare Research and Quality, Draft Report Quality, Regulation and Clinical Utility of Laboratory-developed Tests, September 2009

United States Patent and Trademark Office’s (USPTO) request for comments on its “Interim Examination Instructions for Evaluating Patent Subject Matter Eligibility,” September 2009

Food and Drug Administration, request for comments, “Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs),” October 2014

 Departments of Treasury, Labor, and Health and Human Services, Proposed Rule: “Short-Term, Limited-Duration Insurance,” April 2018

 Department of Health and Human Services, Centers for Medicare and Medicaid Services, Proposed Rule: “Medicaid Program: Reassignment of Medicaid Provider Claims,” July 2018

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