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Policy Resources

  • Health and Human Services (HHS)
    • The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. 
  • Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS)
    • The charge of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) includes:
    • Assessing how genetic technologies are being integrated into health care and public health,
    • Studying the clinical, public health, ethical, economic, legal, and societal implications of genetic and genomic technologies and applications,
    • Identifying opportunities and gaps in research and data collection analysis efforts,
    • Examining the impact of current patent policy and licensing practices on access to genetic technologies,
    • Analyzing uses of genetic information in education, employment, insurance, and law,
    • Serving as a public forum for discussion of issues raised by genetic and genomic technologies.        
    • The SACGHS is chartered to have up to 17 members from authorities knowledgeable about biomedical sciences, human genetics, health care delivery, evidence-based practice, public health, behavioral sciences, social sciences, health services research, health policy, health disparities, ethics, economics, law, health care financing, consumer issues, and other relevant fields. The committee also includes nonvoting ex officio members from 19 federal agencies and departments.
    • Comments on SACGHS Draft Report "Coverage and Reimbursement of Genetic Tests and Services"
  • Food and Drug Administration (FDA)
    • FDA is an agency within the Department of Health and Human Services and consists of centers and offices, which are listed in the menu below. 
    • The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, products that emit radiation, and tobacco products. 
    • The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.   

    • PMC Comments on Development of Companion Diagnostics and the April 2005 Food and Drug Administration (ÒFDAÓ) Drug-Diagnostic Co-Development Concept Paper-December 2009 (PDF)
    • Press Release: January 19, 2011-FDA to improve most common review path for medical devices
    • Advancing Regulatory Science for Public Health-A Framework for FDA's Regulatory Science Initiative
    • Comprehensive List of Guidance Documents at the Food and Drug Administration
    • PMC Statement in support of the FDA Guidelines for Submission of Pharmacogenomic Data  

    • For more information about the FDA visit the following links:
    • Organization Charts
    • About the Office of the Commissioner
    • About the Center for Biologics Evaluation and Research
    • About the Center for Devices and Radiological Health
    • About the Center for Drug Evaluation and Research
    • About the Center for Food Safety and Applied Nutrition
    • About the Center for Tobacco Products About the Center for Veterinary Medicine
    • About the National Center for Toxicological Research
    • About the Office of Regulatory Affairs
  • FDA Personalized Medicine Guidance
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  • Centers for Medicare and Medicaid Services (CMS)
    • CMS' Mission
    • To ensure effective, up-to-date health care coverage and to promote quality care for beneficiaries   

    • CMS' Vision
    • To achieve a transformed and modernized health care system.
    • CMS will accomplish our mission by continuing to transform and modernize America's health care system. 
    • CMS' Strategic Action Plan Objectives
    • Skilled, Committed, and Highly-Motivated Workforce
    • Accurate and Predictable Payments
    • High-Value Health Care
    • Confident, Informed Consumers
    • Collaborative Partnerships 

    • Fair and Rational Medicare Payment for Molecular Diagnostic Tests
    • Policy Position
    • Background  

    • CLIA and Genetic Testing
    • Policy Position
    • Policy Background
  • Centers for Disease Control and Prevention
    • CDC request for public input on public health genomics  
    • The Centers for Disease Control and Prevention (CDC) issued a Request for Information for comments, data, and other information helpful to assess the most important steps in research, policy, and practice for the field of public health genomics in the next five years.
    • Read PMC's comment here.  

    • Evaluation of Genomic Applications in Practice and Prevention (EGAPPª)  
    • In 2004, the Centers for Disease Control and Prevention launched the EGAPPª initiative to establish and test a systematic, evidence-based process for evaluating genetic tests and other applications of genomic technology that are in transition from research to clinical and public health practice. 
    • A key EGAPPª goal is to provide objective, timely, and credible information that is clearly linked to available scientific evidence. This information will allow health care providers and payers, consumers, policymakers, and others to distinguish genetic tests that are safe and useful.
    • Read more about the EGAPPª initiative in the decade report (10 Years of Public Health Genomics at CDC 1997 - 2007)

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