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Healthcare, Regulatory and Reimbursement Landscape - US - Product Image

Healthcare, Regulatory and Reimbursement Landscape - US

  • Published: February 2012
  • Region: United States
  • 253 pages
  • GlobalData

Healthcare, Regulatory and Reimbursement Landscape - US

Summary

Industry analysis specialist GlobalData, has released its new report, “Healthcare, Regulatory and Reimbursement Landscape - US”. The report is an essential source of information and an analysis on the healthcare, regulatory and reimbursement landscape of the US. It identifies the key trends in the healthcare market of the US and provides insights on the demographic, regulatory, reimbursement landscape and healthcare infrastructure of the US. Most importantly, the report provides valuable insights on the trends and segmentation of pharmaceutical and medical devices market. This report is built using data and information sourced from proprietary databases, secondary research and in-house analysis by GlobalData’s team of industry experts.

The US was the third most populated country in the world with a population of about 310 million in 2010. The population of the US is increasing due to a higher birth rate as compared to other major geographies as well as a higher net rate of immigration. However, the decline in the population of the working age group and increasing elderly population READ MORE >

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1

1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Report Guidance
3 Overview of the Pharmaceutical and Medical Devices Market
3.1 Pharmaceutical Market
3.1.1 Market Overview
3.1.2 Supply Channels
3.1.3 Market Segments
3.1.4 Overview of Major Disease Segments
3.1.5 Major Players
3.2 Medical Device Market
3.2.1 Market Overview
3.2.2 Overview of Top Five Segments
3.2.3 Major Players
3.3 Market Drivers and Barriers
3.3.1 Drivers
3.3.2 Barriers
4 Market Access
4.1 Reimbursement and Payer Landscape
4.1.1 Health Insurance and Managed Care in the US
4.1.2 Overview of Insurance Providers
4.1.3 Patients Share in Healthcare Spending
4.1.4 Prescription Drug Price Trend
4.1.5 Pricing Policies
4.2 Regulatory Landscape
4.2.1 Overview of Regulatory Agencies
4.2.2 New Drug Approval Process
4.2.3 New Medical Device Approval Process
4.2.4 Licensing Process for Pharmaceutical and Medical Device Manufacturing
4.2.5 Licensing Process for Exports and Imports
4.2.6 Intellectual Property Rights
4.2.7 Clinical Trial Regulations
4.2.8 Pharmaceutical Advertising Regulations
4.2.9 Pharmacy Regulations
4.2.10 Labeling and Packaging Regulations
5 Country Analysis
5.1 Political Environment
5.1.1 Political Structure
5.1.2 Analysis of Current Political Environment
5.1.3 Healthcare Policy Initiatives
5.2 Economic Landscape
5.3 Economic Indicators
5.3.1 Gross Domestic Product
5.3.2 Gross National Income
5.3.3 Inflation
5.3.4 Currency Exchange Rate
5.3.5 Foreign Direct Investment
5.3.6 Foreign Exchange Reserve
5.3.7 Trade Balance
5.3.8 Government Structural Balance
5.3.9 Government Net Debt
5.3.10 Major Industries
5.4 Demography
5.4.1 Population
5.4.2 Education and Literacy
5.4.3 Employment
5.4.4 Disease Burden
5.5 Healthcare Infrastructure
5.5.1 Healthcare Facilities
5.5.2 Healthcare Parameters
5.5.3 Environmental Health
5.5.4 Healthcare Personnel
5.6 Healthcare Expenditure
5.6.1 Overview
5.6.2 Major Components of Healthcare Spending
5.6.3 Share of Public and Private Sector
5.6.4 Spending in Pharmaceutical R&D
5.7 Trade Associations
5.7.1 The Pharmaceutical Research and Manufacturers of America (PhRMA)
5.7.2 Consumer Healthcare Products Association (CHPA)
5.7.3 International Pharmaceutical Excipients Council (IPEC) of Americas
5.7.4 Advanced Medical Technology Association (AdvaMed)
5.7.5 National Association for Home Care & Hospice (NAHC)
5.7.6 Biotech Industry Association (BIO)
5.7.7 The Society of Chemical Manufacturers and Affiliates (SOCMA)
5.8 Trade Fairs
6 Opportunities and Challenges
6.1 Opportunities
6.2 Challenges
7 Appendix
7.1 Abbreviations
7.2 Methodology
7.2.1 Coverage
7.2.2 Secondary Research
7.2.3 Forecasting
7.2.4 Primary Research
7.2.5 Expert Panel Validation
7.3 Contact Us
7.4 Disclaimer
7.5 Bibliography

1.1 List of Tables
Table 1: Pharmaceutical Market ($bn), the US, 2005 - 2010
Table 2: Pharmaceutical Market ($bn), the US, Forecast, 2011 - 2020
Table 3: Pharmaceutical Market ($bn), by Segment, the US, 2005 - 2010
Table 4: Pharmaceutical Market ($bn), by Segment, the US, Forecast, 2011 - 2020
Table 5: Late-stage (NDA Filed) Pipeline, Major Products, the US, 2011
Table 6: Prices per-30 pill Supply by Type of Pharmacy, Wholesale Price and Drug ($),The US,2009
Table 7: Drugs Going Off-Patent, Global, 2011 - 2012
Table 8: Equilibrium Effects- of Branded Generic Entry, the US, 2005
Table 9: Effects- of Branded Generic Entry on Branded Market Segment, the US, 2005
Table 10: Generic Dispensing by Type of Plan, the US, 2008
Table 11: Health Plan Spending for Severely Ill Patient, Share (%), the US, 2008
Table 12: Top Medicare Part B Biologics, by Spending ($bn), the US, 2007
Table 13: Top Medicare Part D Biologics by Spending ($m), the US, 2006 - 2007
Table 14: Top Selling Biologics, the US, Monthly Cost ($), 2007
Table 15: Variation in Prices of OTC and Prescription Drugs, 2005
Table 16: Major Disease Segments, the US, Expenditure ($m), 2008
Table 17: Major Products, Pfizer, Global, Revenue ($m), 2010
Table 18: Late Stage Pipeline, Pfizer, 2011
Table 19: Major Products, Merck & Co, Revenue ($m), 2010
Table 20: Late Stage Pipeline, Merck & Co, 2011
Table 21: Major Products, Roche, Global, Revenue ($m), 2010
Table 22: Late Stage Pipeline, Roche, 2011
Table 23: Major Products, Abbott, Global, Revenue ($m), 2010
Table 24: Late Stage Pipeline, Abbott, 2011
Table 25: Major Products, Novartis, Global, Revenue ($m), 2010
Table 26: Planned Filings, Novartis, 2011 to = 2015
Table 27: Medical Device Market ($bn), the US, 2005 - 2010
Table 28: Medical Device Market ($bn), the US, Forecast, 2011 - 2020
Table 29: Medical Device Market, the US, Segment Share (%), 2010
Table 30: Orthopedic Devices Market, ($m), the US, 2005 - 2010
Table 31: Sales Trends for Major Players-, Orthopedic Devices, the US, 2010
Table 32: in Vitro Diagnostics Market ($m), the US, 2005 - 2010
Table 33: Sales Trends for Major Players-, in Vitro Diagnostics, the US, 2010
Table 34: Cardiovascular Devices Market ($m), the US, 2005 - 2010
Table 35: Sales Trends for Major Players-, Cardiovascular Devices, the US, 2010
Table 36: Ophthalmic Devices Market ($m), the US, 2005 - 2010
Table 37: Sales Trends for Major Players-, Ophthalmic Devices, the US, 2010
Table 38: Hospital Supplies Market ($m), the US, 2005 - 2010
Table 39: Sales Trends for Major Players-, Hospital Supplies, the US, 2010
Table 40: Major Medical Device Companies, the US, Revenues ($m), 2010
Table 41: Major Products, Medtronic, Global, Revenue ($m), 2011
Table 42: Major Products, Boston, Global, Revenue ($m), 2010
Table 43: Major Products, Abbott, Global, Revenue ($m), 2010
Table 44: Late Stage Pipeline, Abbott, 2011
Table 45: Late Stage Pipeline, GE Healthcare, 2011
Table 46: Major Products, Siemens, Global, Revenue ($m), 2010
Table 47: Health Maintenance Organizations (HMOs), Number, Enrollment and Penetration, the US,2010(July)
Table 48: Insurance Options by Patients Segments, the US, 2011
Table 49: Total Medicare Income, Expenditures and Trust Fund Assets, ($bn), the US, 2005 - 2020
Table 50: Coverage by Type of Health Insurance (m), the US, 2009 - 2010
Table 51: Insurance Coverage Through Private Sector Establishments, the US,2010
Table 52: Healthcare Spending, the US, Out-of-Pocket (%), 2005 - 2010
Table 53: Out-of-Pocket Share by Type of Expenditure (%), the US, 2008
Table 54: Change in Average Price of Prescription Drugs (%), the US, 2007 - 2010
Table 55: Clinical Trial Phases
Table 56: New Drugs Approved by FDA, the US, 1996 - 2010
Table 57: Documents Required to Commence Clinical Trial, the US, 2011
Table 58: American Jobs Act, 2011
Table 59: GDP Per Capita, ($), the US, 2005 - 2010
Table 60: GDP Per Capita ($), the US, Forecast, 2011 - 2020
Table 61: GDP, the US, Annual Growth (%), 2005 - 2010
Table 62: GDP, the US, Annual Growth (%), Forecast, 2011 - 2020
Table 63: GNI Per Capita ($), the US, 2005 - 2010
Table 64: Average Consumer Price Index, the US, 2005 - 2010
Table 65: Average Consumer Price Index, the US, Forecast, 2011 - 2020
Table 66: Average Consumer Price, the US, Annual Change (%), 2005 - 2010
Table 67: Average Consumer Price, the US, Annual Change (%), Forecast, 2011 - 2020
Table 68: Currency Exchange Rate (JPY/$), the US, 2005 - 2010
Table 69: Currency Exchange Rate (£/$), the US, 2005 - 2010
Table 70: Currency Exchange Rate (€/$), the US, 2005 - 2010
Table 71: Foreign Direct Investment ($bn), the US, 2005 - 2010
Table 72: Forex Reserve ($bn), the US, 2005 - 2010
Table 73: Trade Balance ($bn), the US, 2005 - 2010
Table 74: Imports of Goods and Services ($bn), the US, 2005 - 2010
Table 75: Export of Goods and Services ($bn), the US, 2005 - 2010
Table 76: General Government Structural Balance ($bn), the US, 2005 - 2010
Table 77: General Government Structural Balance ($bn), the US, Forecast, 2011 - 2020
Table 78: General Government Net Debt ($bn), the US, 2005 - 2010
Table 79: General Government Net Debt ($bn), the US, Forecast, 2011 - 2020
Table 80: Major Industries, the US, GDP ($bn), 2010
Table 81: Population (m), the US, 2005 - 2010
Table 82: Population (m), the US, Forecast, 2011 - 2020
Table 83: Urban and Rural Population, the US, Share (%), 2005 - 2010
Table 84: Age Groups, Population Distribution (%), the US, 2005 - 2010
Table 85: Age Groups, Population Distribution (%), the US, Forecast, 2011 - 2020
Table 86: Births (Per 1,000 Population), the US, 2005 - 2010
Table 87: Births (Per 1,000 Population), the US, Forecast, 2011 - 2020
Table 88: Mortality (Per 1,000 Population), the US, 2005 - 2010
Table 89: Mortality (Per 1,000 Population), the US, Forecast, 2011 - 2020
Table 90: Major Causes of Mortality, the US, 2008
Table 91: Children <5 Years Age, the US, Mortality Rate (Per 1,000 Live Births), 1990 - 2009
Table 92: Immunization Rate for Measles (%), the US, 2005 - 2010
Table 93: Maternal Mortality (Per 100,000 Live Births), the US, 1990 - 2008
Table 94: Major Causes of Male Mortality, the US, 2008
Table 95: Major Causes of Female Mortality, the US, 2008
Table 96: Gender Ratio (Male/Female), the US, 2005 - 2010
Table 97: Gender Ratio (Male/Female), the US, Forecast, 2011 - 2020
Table 98: Life Expectancy at Birth, the US, 2005 - 2010
Table 99: Life Expectancy at Birth, the US, Forecast, 2011 - 2020
Table 100: Life Expectancy at 65 Years, the US, 2005 - 2010
Table 101: Life Expectancy at 65 Years, the US, Forecast, 2011 - 2020
Table 102: Students, the US, 2005 - 2010
Table 103: Students Enrollment by Level of Education, the US, 2010
Table 104: Number of Employed Individuals (m), the US, 2005 - 2010
Table 105: Employment (m), the US, Forecast, 2011 - 2020
Table 106: Unemployment Rate (%), the US, 2005 - 2010
Table 107: Unemployment Rate (%), the US, Forecast, 2011 - 2020
Table 108: Major Diseases, the US, DALYs (Per 100,000 Population), 2004
Table 109: Hospitals, the US, Federal and Non-Federal, 2005 - 2010
Table 110: Community Hospitals, the US, 2005 - 2010
Table 111: Community Hospitals, the US, Forecast, 2011 - 2020
Table 112: Non-Federal Hospitals, the US, 2005 - 2010
Table 113: Patients, the US, Share by Standard of Care (%), 2010
Table 114: Community Hospitals Distribution by Bed Size (%), the US, 2006
Table 115: Hospital Beds, the US, Share, 2005 - 2010
Table 116: Non-Federal Hospital Beds (Thousands), the US, Share, 2005 - 2010
Table 117: Community Hospital Beds, the US, Share, 2005 - 2010
Table 118: Community Hospitals in Urban and Rural Areas, the US, 2005 - 2010
Table 119: MRI Units (Per 100,000 Population), the US, 2005 - 2010
Table 120: CT Scanners (Per 100,000 Population), the US, 2005 - 2010
Table 121: Beds (Per 1,000 Population), the US, 2005 - 2010
Table 122: Physicians (Per 1,000 Population), the US,2005 - 2010
Table 123: Nurses (Per 1,000 Population), the US,2005 - 2010
Table 124: Emission of Pollutants (Thousand Tons), the US, 1990 - 2010
Table 125: CO (Thousand Tons), the US, 1990 - 2010
Table 126: Lead (Thousand Tons), the US, 1990 - 2010
Table 127: Healthcare Personnel, the US, 2010
Table 128: Healthcare Expenditure (% of GDP), the US, 2005 - 2010
Table 129: Healthcare Expenditure, the US, Share of Major Components (%), 2009
Table 130: Healthcare Expenditure, the US, Pharmaceuticals Share (%), 2005 - 2010
Table 131: Healthcare Expenditure, the US, Public and Private Share (%), 2005 - 2010
Table 132: Pharmaceutical R&D Expenditure ($bn), the US, 2005 - 2010
Table 133: Major Healthcare Trade Fairs,The US, 2011 - 2012

1.2 List of Figures
Figure 1: Pharmaceutical Market ($bn), the US, 2005 - 2010
Figure 2: Pharmaceutical Market ($bn), the US, Forecast, 2011 - 2020
Figure 3: Pharmaceutical Market ($bn), by Segment, the US, 2005 - 2010
Figure 4: Pharmaceutical Market ($bn),by Segment, the US, Forecast, 2011 - 2020
Figure 5: Pharmaceutical Distribution Channel, the US, 2011
Figure 6: Health Plan Spending for Severely Ill Patient, Share(%), the US, 2008
Figure 7: Top Medicare Part B Biologics, by Spending ($bn), the US, 2007
Figure 8: Top Medicare Part D Biologics by Spending ($m), the US, 2006 - 2007
Figure 9: Variation in Prices of OTC and Prescription Drugs, 2005
Figure 10: Major Disease Areas, the US, Expenditure ($m), 2008
Figure 11: Medical Device Market ($bn), the US, 2005 - 2010
Figure 12: Medical Device Market ($bn), the US, Forecast, 2011 - 2020
Figure 13: Medical Device Market, the US, Segment Share (%), 2010
Figure 14: Orthopedic Devices Market, ($m), the US, 2005 - 2010
Figure 15: Sales Trends for Major Players-, Orthopedic Devices, the US, 2005 - 2010
Figure 16: in Vitro Diagnostics Market ($m), the US, 2005 - 2010
Figure 17: Sales Trends for Major Players-, in Vitro Diagnostics, the US, 2005 - 2010
Figure 18: Cardiovascular Devices Market ($m), the US, 2005 - 2010
Figure 19: Sales Trends for Major Players-, Cardiovascular Devices, the US, 2005 - 2010
Figure 20: Ophthalmic Devices Market ($m), the US, 2005 - 2010
Figure 21: Sales Trends for Major Players-, Ophthalmic Devices, the US, 2005 - 2010
Figure 22: Hospital Supplies Market ($m), the US, 2005 - 2010
Figure 23: Sales Trends for Major Players-, Hospital Supplies, the US, 2005 - 2010
Figure 24: Major Medical Device Companies, the US, Revenues ($m), 2010
Figure 25: Growth in Health Care Expenditures Attributable to Prescription Drugs, the US, 1996 - 2008
Figure 26: Drug Development Costs, the US, 1975-2005
Figure 27: Patent Challenges by Generic Companies, the US, 2000-2008
Figure 28: Drivers and Barriers, Healthcare Market, the US, 2011
Figure 29: Pricing and Reimbursement Process, the US, 2011
Figure 30: Role of Pharmacy Benefit Managers in the Healthcare System, the US, 2011
Figure 31: Payer Strategies for Promoting the Use of Generics and Low Cost Brands, the US, 2011
Figure 32: Healthcare System Financial Flow, the US, 2011
Figure 33: Healthcare Spending, the US, Out-of-Pocket (%), 2005 - 2010
Figure 34: Out-of-Pocket Share by Type of Expenditure (%), the US, 2008
Figure 35: Change in Average Price of Prescription Drugs (%), the US, 2007 - 2010
Figure 36: Tier Structure of Formulary, the US, 2011
Figure 37: Structure of Food and Drug Administration (FDA) the US, 2011
Figure 38: Outline of the Clinical Development Process for a New Drug
Figure 39: New Drug Approval Process Outline, the US, 2011
Figure 40: New Drug Approval Process, the US, 2011
Figure 41: New Drugs Approved by FDA, the US, 1996 - 2010
Figure 42: Medical Device Approval Process, the US, 2011
Figure 43: Patent Approval Process, the US, 2011
Figure 44: Biopharmaceutical Patents by Location of Inventors, the US, 1990 - 2002
Figure 45: GDP Per Capita, ($), the US, 2005 - 2010
Figure 46: GDP Per Capita ($), the US, Forecast, 2011 - 2020
Figure 47: GDP, the US, Annual Growth (%), 2005 - 2010
Figure 48: GDP, the US, Annual Growth (%), Forecast, 2011 - 2020
Figure 49: GNI Per Capita ($), the US, 2005 - 2010
Figure 50: Average Consumer Price Index, the US, 2005 - 2010
Figure 51: Average Consumer Price Index, the US, Forecast, 2011 - 2020
Figure 52: Average Consumer Price, the US, Annual Change (%), 2005 - 2010
Figure 53: Average Consumer Price, the US, Annual Change (%), Forecast, 2011 - 2020
Figure 54: Currency Exchange Rate (JPY/$), the US, 2005 - 2010
Figure 55: Currency Exchange Rate (£/$), the US, 2005 - 2010
Figure 56: Currency Exchange Rate (€/$), the US, 2005 - 2010
Figure 57: Foreign Direct Investment ($bn), the US, 2005 - 2010
Figure 58: Forex Reserve ($bn), the US, 2005 - 2010
Figure 59: Trade Balance ($bn), the US, 2005 - 2010
Figure 60: Imports of Goods and Services ($bn), the US, 2005 - 2010
Figure 61: Export of Goods and Services ($bn), the US, 2005 - 2010
Figure 62: General Government Structural Balance ($bn), the US, 2005 - 2010
Figure 63: General Government Structural Balance ($bn), the US, Forecast, 2011 - 2020
Figure 64: General Government Net Debt ($bn), the US, 2005 - 2010
Figure 65: General Government Net Debt ($bn), the US, Forecast, 2011 - 2020
Figure 66: Major Industries, the US, GDP ($bn), 2010
Figure 67: Population (m), the US, 2005 - 2010
Figure 68: Population (m), the US, Forecast, 2011 - 2020
Figure 69: Urban and Rural Population, the US, Share (%), 2005 - 2010
Figure 70: Age Groups, Population Distribution (%), the US, 2005 - 2010
Figure 71: Age Groups, Population Distribution (%), the US, Forecast, 2011 - 2020
Figure 72: Births (Per 1,000 Population), the US, 2005 - 2010
Figure 73: Births (Per 1,000 Population), the US, Forecast, 2011 - 2020
Figure 74: Mortality (Per 1,000 Population), the US, 2005 - 2010
Figure 75: Mortality (Per 1,000 Population), the US, Forecast, 2011 - 2020
Figure 76: Major Causes of Mortality (Thousands), the US, 2008
Figure 77: Children <5 Years Age, the US, Mortality Rate (Per 1,000 Live Births), 1990 - 2009
Figure 78: Immunization Rate for Measles (%), the US, 2005 - 2010
Figure 79: Maternal Mortality (Per 100,000 Live Births), the US, 1990 - 2008
Figure 80: Major Causes of Male Mortality (Thousands), the US, 2008
Figure 81: Major Causes of Female Mortality (Thousands), the US, 2008
Figure 82: Gender Ratio (Male/Female), the US, 2005 - 2010
Figure 83: Gender Ratio (Male/Female), the US, Forecast, 2011 - 2020
Figure 84: Life Expectancy at Birth, the US, 2005 - 2010
Figure 85: Life Expectancy at Birth, the US, Forecast, 2011 - 2020
Figure 86: Life Expectancy at 65 Years, the US, 2005 - 2010
Figure 87: Life Expectancy at 65 Years, the US, Forecast, 2011 - 2020
Figure 88: Students (Thousands), the US, 2005 - 2010
Figure 89: Students Enrollment by Level of Education, the US, 2010
Figure 90: Number of Employed Individuals (m), the US, 2005 - 2010
Figure 91: Employment (m), the US, Forecast, 2011 - 2020
Figure 92: Projected Change in Employment in Selected Sectors from ('000), the US, 2006- 2018
Figure 93: Unemployment Rate (%), the US, 2005 - 2010
Figure 94: Unemployment Rate (%), the US, Forecast, 2011 - 2020
Figure 95: Major Diseases, the US, DALYs (Per 100,000 Population), 2004
Figure 96: Annual Change in Death Rate from Cancer, the US, 1975-2006
Figure 97: Annual Change in Death Rate from Cancer, the US, 1975-2006
Figure 98: Hospitals, the US, Federal and Non-Federal, 2005 - 2010
Figure 99: Community Hospitals, the US, 2005 - 2010
Figure 100: Community Hospitals, the US, Forecast, 2011 - 2020
Figure 101: Non-Federal Hospitals, the US, 2005 - 2010
Figure 102: Patients, the US, Share by Standard of Care (%), 2010
Figure 103: Community Hospitals Distribution by Bed Size (%), the US, 2006
Figure 104: Hospital Beds (Thousands), the US, Share, 2005 - 2010
Figure 105: Non-Federal Hospital Beds (Thousands), the US, Share, 2005 - 2010
Figure 106: Community Hospital Beds (Thousands), the US, Share, 2005 - 2010
Figure 107: Community Hospitals in Urban and Rural Areas, the US, 2005 - 2010
Figure 108: MRI Units (Per 100,000 Population), the US, 2005 - 2010
Figure 109: CT Scanners (Per 100,000 Population), the US, 2005 - 2010
Figure 110: Beds (Per 1,000 Population), the US, 2005 - 2010
Figure 111: Physicians (Per 1,000 Population), the US,2005 - 2010
Figure 112: Nurses (Per 1,000 Population), the US,2005 - 2010
Figure 113: Emission of Pollutants (Thousand Tons), the US, 1990 - 2010
Figure 114: CO (Thousand Tons), the US, 1990 - 2010
Figure 115: Lead (Thousand Tons), the US, 1990 - 2010
Figure 116: Healthcare Personnel, the US, 2010
Figure 117: Healthcare Expenditure (% of GDP), the US, 2005 - 2010
Figure 118: Healthcare Expenditure, the US, Share of Major Components (%), 2009
Figure 119: Healthcare Expenditure, the US, Pharmaceuticals Share (%), 2005 - 2010
Figure 120: Healthcare Expenditure, the US, Public and Private Share (%), 2005 - 2010
Figure 121: Pharmaceutical R&D Expenditure ($bn), the US, 2005 - 2010
Figure 122: Opportunities and Challenges, Healthcare Market, the US, 2011

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