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Pages 351-364

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From page 351... ... , 115n, 126n, direct controls, 268 318 performance standards rather than Administrative guidance, history of design standards, 267 regulatory analysis, 22 Alternatives, evaluation of, 277�278 Administrative Procedure Act (APA) , 21 American Petroleum Institute v. Read the entire page →
From page 352... ... , 1�4, 7, 10�12, of cost-effectiveness, 36�37 15�22, 27�59, 64, 67, 129�134, of health gains, 149�151 143�146, 151, 157, 168�174, 178� Carter, Jimmy, 22 182, 188�189, 194, 197, 204, 214, Case study analytic approach, 193�244 217, 229, 238, 241, 269�272, 292, conclusion, 240�241 300, 318 EPA's nonroad engine air emissions calculation of net benefits, 31 regulation, 228�240 valuation approach, 29�30 FDA's juice processing regulation, 204� Benefit point transfer, 289 215 Benefits, 4, 318 general approach, 195�203 Benefits analysis guidelines, 51�55 NHTSA estimates of annual quantified monetized health-adjusted life years in benefits, 218 NHTSA's child restraints regulation, benefit�cost analysis, 53 OMB criteria for evaluating stated 215�228 purpose and scope, 193�195 preference studies, 54 Benefits and costs Case study process, 196 ancillary benefits and countervailing Category rating (CR) , 77�81, 98 risks, 289�290 CDS. Read the entire page →
From page 353... ... See Cost of illness Contingent valuation approach, 125, 318 Collecting data and conducting research to "Control of Emissions from Nonroad Diesel improve HRQL measurement and Engines," 303 regulatory CEA, 13�14 Convergent validity, 318 recommendation 10, 13 Correlations, 318 recommendation 11, 13 and conversions among HRQL recommendation 12, 13�14 measures, 123�124 Committee on Estimating the Health-Risk and cross-walks of HRQL measures, Reduction Benefits of Proposed Air 126�127 Pollution Regulations, 18 Corrosion Proof Fittings v. EPA, 45 Committee on Summary Measures of Cost, 319 Population Health, 18 Cost-effectiveness analysis (CEA) Read the entire page →
From page 354... ... , 218 Direct non-health care costs, 33 Criteria for selecting integrated effectiveness Direct rating, category rating and visual measures for regulatory CEA, 7, 162 analogue scales, 79�80 Criteria for selecting HALY metrics for Direct uses of market data, 283�284 regulatory CEA, 68�72 Disability, defined, 319 standard performance criteria for HRQL Disability-adjusted life year (DALY) , 80�81, instruments, 70 88�91, 319 Criterion validity, 319 the WHO's DALY, 89 Cryptosporidium parvum, 204�210 Disaggregated impacts, 176�177 Current practices for regulatory analysis, Disclosure, full, 314 50�65 Discount rates, 296�303 benefits analysis guidelines, 51�55 intergenerational discounting, 301�302 current valuation practices, 55�62 the rationale for discounting, 297�298 key analytic requirements of OMB real discount rates of 3 percent and 7 guidelines, 51 percent, 298�300 other guidelines relavant to CEA, 62�65 social, 323 Current valuation practices, 55�62 time preference for health-related EPA's morbidity inclusive life year benefits and costs, 300�301 (MILY) Read the entire page →
From page 355... ... See EuroQoL-5D and number of attribute levels for Equivalent lives saved (ELS) , 60, 215�217, generic HRQL indexes, 95 273 Double-counting issues, 30, 62 Escherichia coli O157:H7, 204�210 Estimates of QALY gains, 207�212, 223� 228, 233�237 E HRQL with illness at average age of incidence, 235 Economic analysis, the role of, 19�26 HRQL with injury, 227 Economic efficiency, 319�320 HRQL with pathogen-related illness, 208 Economic regulation, the presumption QALY total losses, 210, 224, 236 against, 265 sensitivity analysis for QALY losses, Economic values of uncertain outcomes, 310 211, 226, 237 "Economically significant" regulations, Estimating the Contributions of Lifestyle defining, 24 Related Factors to Preventable Effective date, 315 Death, 186 Effectiveness Estimating the Public Health Benefits of constructing measures of, 272 Proposed Air Pollution Regulations, selecting integrated measures of, 10�11, 121 272�273 Estimation of costs, 62�63 Effectiveness metric, for public health and Estimation of "with condition" HRQL, safety rulemakings, 272�274 198�199 ELS. Read the entire page →
From page 356... ... , 103, 198, Expert assignment of health states, using 215, 222�226, 254�257 generic HRQL instruments, 110�111 Functional status, 74, 320 Externality, common property resource and Future generations in CEA, 152�154 public good, 262�263 discounting and timing of impacts, 153 "Extra-welfarists," 27 Read the entire page →
From page 357... ... , 129, 133�137, 148�150, 156, 160� 199 170, 177�189, 195�209, 214�218, Center for Risk Analysis, 117 222, 227, 232�241, 273, 320 Health-adjusted life years (HALYs) , 2�10, with illness at average age of incidence, 15�19, 27�28, 32�40, 52�56, 63�91, 235 122, 135, 159�163, 181, 320 with injury, 227 alternative HALY metrics for regulatory measurement and regulatory CEA, CEA, 86�91 conducting research to improve, 13� describing health states, 74�76 14 Read the entire page →
From page 358... ... See International Classification of 102�106 Disease codes generic HRQL indexes, 93�102 Immediate activities of daily living (IADL) , health state index values from prior 115n studies and benefits transfer, 116� Impacts 121 on children, 312 primary elicitation of condition-specific determining the distribution of, 64 index values, 92�93 on small businesses and other small uncertainty in health status and entities, 310�311 preference measurement, 121�123 Indirect uses of market data, 284�285 Health states, 74, 320 Individual preferences, and societal values, changes in, 136 138�139 concepts and domains used in defining Informal caregiver time, 33 self-reported health status, quality of Information collection, paperwork, and life, and health-related quality of life, recordkeeping burdens, 311 76 Information needed for regulatory decision describing, 74�76 making, 12�13, 181�184 health-adjusted life years, 75 distributional and other aspects of risk "postregulatory," 8 and regulation, 183 Health Utilities Index (HUI) Read the entire page →
From page 359... ... See Intrarater test 60�61, 216�218, 222 retest reliability categories used in NHTSA analyses, 58 Intrarater test-retest reliability, 321 Maximum Abbreviated Injury Scale 2 of the SG, TTO and visual analogue (MAIS 2) , 225 scale techniques, 82 Medical Expenditure Panel Survey (MEPS) Read the entire page →
From page 360... ... , 126n 279, 313�315 National Research Council Circular A-4, 3, 16, 23, 40, 50, 53�56, Board on Environmental Studies and 62�65, 134, 146, 152�154, 174, Toxicology, 121 194�196, 217, 258�315 Committee on Estimating the Health criteria for evaluating stated preference Risk-Reduction Benefits of Proposed studies, 54 Air Pollution Regulations, 18, 185 rationale for requiring CEA as part of NEPA. See National Environmental Policy regulatory analysis, 17 Act OIRA. Read the entire page →
From page 361... ... See Particulate matter emissions total losses, 210, 224, 236 Population-based, condition-specific HRQL Quality of Life Instruments Database, 102n values, 112�113 Quality of Well-Being Scale (QWB) , 6, 58� Population health data, and subgroups, 59, 71�72, 97�98, 114, 122, 165� 148�149 166, 198�204, 212�215, 222�227, Population survey data-based approaches, 245�246 110�116 availability, 98 catalogues of chronic condition HRQL domains, 98 values, 111�113 history, 97�98 incorporation of health profiles and self-administered version, 98 HRQL questions and instruments in valuation, 98 routine population surveys, 114�116 Quantified benefits, 313 sources for population-based, condition EPA estimates of annual, 230 specific HRQL values, 112�113 of EPA's nonroad diesel rule, 56 statistically inferred HRQL values, 114 of the FDA's juice processing rule, 57 "Postregulatory" health status, 8 QWB. Read the entire page →
From page 362... ... See "Regulatory flexiblity analysis" enforcement, 157 RIA, 279 presenting information needed for, 12� "Risk neutrality," 310 13 Risk-related considerations for regulatory publicity, 157 decisions, 145 relevance, 157 "Risk�risk" analysis, 49 revisability and appeals, 157 Risks Regulatory development with delayed effects, 142 and economic analysis, 3�4 detecting, 141�142, 145 key requirements of the Administrative dimensions of value affecting the Procedure Act, 21 acceptability of, 140�143 process of, 20�22 and dread, 142, 145 requirements for regulatory analysis and personal control over, 142, 145 decision making, 22�26 treatment of, 314 the role of economic analysis in, 19�26 Routine population surveys, incorporation Regulatory Flexiblity Act, 267, 310 of health profiles and HRQL "Regulatory flexiblity analysis" (RFA) , questions and instruments in, 114� 310�311 116 Regulatory interventions, 10 RS. Read the entire page →
From page 363... ... See Toxic Substances Control Act "Social rate of time preference," 299 TTO. See Time trade-off Special populations, 104�105 TTO method and discounting, 84 Specialized analytical requirements, 310� 313 analysis of unfunded mandates, 311 U energy impacts, 312�313 environmental impact statements, 312 Uncertain outcomes, economic values of, impact on small businesses and other 310 small entities, 310�311 Uncertainty impacts on children, 312 alternative assumptions, 310 information collection, paperwork, and assessing, 64 recordkeeping burdens, 311 economic values of uncertain outcomes, information quality guidelines, 311�312 310 SPM. Read the entire page →
From page 364... ... , 59, comparison to "with condition" values 295 based on expert assignment, 202 Valuing Health Outcomes conference, 17 comparison to "with condition" values Valuing health states and preference based on patient self-assessments, elicitation methods, 77�86 202�203, 211 comparisons among elicitation methods, "Without condition" values, 234 81�86 "Without pathogen-related illness," 215 direct rating -- category rating and visual World Health Organization (WHO) , 87�89, analogue scales, 79�80 126n person trade-off, 80�81 Global Burden of Disease, 81 standard gamble, 78 WTA. Read the entire page →

From page 351...

... , 115n, 126n, direct controls, 268 318 performance standards rather than Administrative guidance, history of design standards, 267 regulatory analysis, 22 Alternatives, evaluation of, 277�278 Administrative Procedure Act (APA) , 21 American Petroleum Institute v.

Read the entire page →

From page 352...

... , 1�4, 7, 10�12, of cost-effectiveness, 36�37 15�22, 27�59, 64, 67, 129�134, of health gains, 149�151 143�146, 151, 157, 168�174, 178� Carter, Jimmy, 22 182, 188�189, 194, 197, 204, 214, Case study analytic approach, 193�244 217, 229, 238, 241, 269�272, 292, conclusion, 240�241 300, 318 EPA's nonroad engine air emissions calculation of net benefits, 31 regulation, 228�240 valuation approach, 29�30 FDA's juice processing regulation, 204� Benefit point transfer, 289 215 Benefits, 4, 318 general approach, 195�203 Benefits analysis guidelines, 51�55 NHTSA estimates of annual quantified monetized health-adjusted life years in benefits, 218 NHTSA's child restraints regulation, benefit�cost analysis, 53 OMB criteria for evaluating stated 215�228 purpose and scope, 193�195 preference studies, 54 Benefits and costs Case study process, 196 ancillary benefits and countervailing Category rating (CR) , 77�81, 98 risks, 289�290 CDS.

Read the entire page →

From page 353...

... See Cost of illness Contingent valuation approach, 125, 318 Collecting data and conducting research to "Control of Emissions from Nonroad Diesel improve HRQL measurement and Engines," 303 regulatory CEA, 13�14 Convergent validity, 318 recommendation 10, 13 Correlations, 318 recommendation 11, 13 and conversions among HRQL recommendation 12, 13�14 measures, 123�124 Committee on Estimating the Health-Risk and cross-walks of HRQL measures, Reduction Benefits of Proposed Air 126�127 Pollution Regulations, 18 Corrosion Proof Fittings v. EPA, 45 Committee on Summary Measures of Cost, 319 Population Health, 18 Cost-effectiveness analysis (CEA)

Read the entire page →

From page 354...

... , 218 Direct non-health care costs, 33 Criteria for selecting integrated effectiveness Direct rating, category rating and visual measures for regulatory CEA, 7, 162 analogue scales, 79�80 Criteria for selecting HALY metrics for Direct uses of market data, 283�284 regulatory CEA, 68�72 Disability, defined, 319 standard performance criteria for HRQL Disability-adjusted life year (DALY) , 80�81, instruments, 70 88�91, 319 Criterion validity, 319 the WHO's DALY, 89 Cryptosporidium parvum, 204�210 Disaggregated impacts, 176�177 Current practices for regulatory analysis, Disclosure, full, 314 50�65 Discount rates, 296�303 benefits analysis guidelines, 51�55 intergenerational discounting, 301�302 current valuation practices, 55�62 the rationale for discounting, 297�298 key analytic requirements of OMB real discount rates of 3 percent and 7 guidelines, 51 percent, 298�300 other guidelines relavant to CEA, 62�65 social, 323 Current valuation practices, 55�62 time preference for health-related EPA's morbidity inclusive life year benefits and costs, 300�301 (MILY)

Read the entire page →

From page 355...

... See EuroQoL-5D and number of attribute levels for Equivalent lives saved (ELS) , 60, 215�217, generic HRQL indexes, 95 273 Double-counting issues, 30, 62 Escherichia coli O157:H7, 204�210 Estimates of QALY gains, 207�212, 223� 228, 233�237 E HRQL with illness at average age of incidence, 235 Economic analysis, the role of, 19�26 HRQL with injury, 227 Economic efficiency, 319�320 HRQL with pathogen-related illness, 208 Economic regulation, the presumption QALY total losses, 210, 224, 236 against, 265 sensitivity analysis for QALY losses, Economic values of uncertain outcomes, 310 211, 226, 237 "Economically significant" regulations, Estimating the Contributions of Lifestyle defining, 24 Related Factors to Preventable Effective date, 315 Death, 186 Effectiveness Estimating the Public Health Benefits of constructing measures of, 272 Proposed Air Pollution Regulations, selecting integrated measures of, 10�11, 121 272�273 Estimation of costs, 62�63 Effectiveness metric, for public health and Estimation of "with condition" HRQL, safety rulemakings, 272�274 198�199 ELS.

Read the entire page →

From page 356...

... , 103, 198, Expert assignment of health states, using 215, 222�226, 254�257 generic HRQL instruments, 110�111 Functional status, 74, 320 Externality, common property resource and Future generations in CEA, 152�154 public good, 262�263 discounting and timing of impacts, 153 "Extra-welfarists," 27

Read the entire page →

From page 357...

... , 129, 133�137, 148�150, 156, 160� 199 170, 177�189, 195�209, 214�218, Center for Risk Analysis, 117 222, 227, 232�241, 273, 320 Health-adjusted life years (HALYs) , 2�10, with illness at average age of incidence, 15�19, 27�28, 32�40, 52�56, 63�91, 235 122, 135, 159�163, 181, 320 with injury, 227 alternative HALY metrics for regulatory measurement and regulatory CEA, CEA, 86�91 conducting research to improve, 13� describing health states, 74�76 14

Read the entire page →

From page 358...

... See International Classification of 102�106 Disease codes generic HRQL indexes, 93�102 Immediate activities of daily living (IADL) , health state index values from prior 115n studies and benefits transfer, 116� Impacts 121 on children, 312 primary elicitation of condition-specific determining the distribution of, 64 index values, 92�93 on small businesses and other small uncertainty in health status and entities, 310�311 preference measurement, 121�123 Indirect uses of market data, 284�285 Health states, 74, 320 Individual preferences, and societal values, changes in, 136 138�139 concepts and domains used in defining Informal caregiver time, 33 self-reported health status, quality of Information collection, paperwork, and life, and health-related quality of life, recordkeeping burdens, 311 76 Information needed for regulatory decision describing, 74�76 making, 12�13, 181�184 health-adjusted life years, 75 distributional and other aspects of risk "postregulatory," 8 and regulation, 183 Health Utilities Index (HUI)

Read the entire page →

From page 359...

... See Intrarater test 60�61, 216�218, 222 retest reliability categories used in NHTSA analyses, 58 Intrarater test-retest reliability, 321 Maximum Abbreviated Injury Scale 2 of the SG, TTO and visual analogue (MAIS 2) , 225 scale techniques, 82 Medical Expenditure Panel Survey (MEPS)

Read the entire page →

From page 360...

... , 126n 279, 313�315 National Research Council Circular A-4, 3, 16, 23, 40, 50, 53�56, Board on Environmental Studies and 62�65, 134, 146, 152�154, 174, Toxicology, 121 194�196, 217, 258�315 Committee on Estimating the Health criteria for evaluating stated preference Risk-Reduction Benefits of Proposed studies, 54 Air Pollution Regulations, 18, 185 rationale for requiring CEA as part of NEPA. See National Environmental Policy regulatory analysis, 17 Act OIRA.

Read the entire page →

From page 361...

... See Particulate matter emissions total losses, 210, 224, 236 Population-based, condition-specific HRQL Quality of Life Instruments Database, 102n values, 112�113 Quality of Well-Being Scale (QWB) , 6, 58� Population health data, and subgroups, 59, 71�72, 97�98, 114, 122, 165� 148�149 166, 198�204, 212�215, 222�227, Population survey data-based approaches, 245�246 110�116 availability, 98 catalogues of chronic condition HRQL domains, 98 values, 111�113 history, 97�98 incorporation of health profiles and self-administered version, 98 HRQL questions and instruments in valuation, 98 routine population surveys, 114�116 Quantified benefits, 313 sources for population-based, condition EPA estimates of annual, 230 specific HRQL values, 112�113 of EPA's nonroad diesel rule, 56 statistically inferred HRQL values, 114 of the FDA's juice processing rule, 57 "Postregulatory" health status, 8 QWB.

Read the entire page →

From page 362...

... See "Regulatory flexiblity analysis" enforcement, 157 RIA, 279 presenting information needed for, 12� "Risk neutrality," 310 13 Risk-related considerations for regulatory publicity, 157 decisions, 145 relevance, 157 "Risk�risk" analysis, 49 revisability and appeals, 157 Risks Regulatory development with delayed effects, 142 and economic analysis, 3�4 detecting, 141�142, 145 key requirements of the Administrative dimensions of value affecting the Procedure Act, 21 acceptability of, 140�143 process of, 20�22 and dread, 142, 145 requirements for regulatory analysis and personal control over, 142, 145 decision making, 22�26 treatment of, 314 the role of economic analysis in, 19�26 Routine population surveys, incorporation Regulatory Flexiblity Act, 267, 310 of health profiles and HRQL "Regulatory flexiblity analysis" (RFA) , questions and instruments in, 114� 310�311 116 Regulatory interventions, 10 RS.

Read the entire page →

From page 363...

... See Toxic Substances Control Act "Social rate of time preference," 299 TTO. See Time trade-off Special populations, 104�105 TTO method and discounting, 84 Specialized analytical requirements, 310� 313 analysis of unfunded mandates, 311 U energy impacts, 312�313 environmental impact statements, 312 Uncertain outcomes, economic values of, impact on small businesses and other 310 small entities, 310�311 Uncertainty impacts on children, 312 alternative assumptions, 310 information collection, paperwork, and assessing, 64 recordkeeping burdens, 311 economic values of uncertain outcomes, information quality guidelines, 311�312 310 SPM.

Read the entire page →

From page 364...

... , 59, comparison to "with condition" values 295 based on expert assignment, 202 Valuing Health Outcomes conference, 17 comparison to "with condition" values Valuing health states and preference based on patient self-assessments, elicitation methods, 77�86 202�203, 211 comparisons among elicitation methods, "Without condition" values, 234 81�86 "Without pathogen-related illness," 215 direct rating -- category rating and visual World Health Organization (WHO) , 87�89, analogue scales, 79�80 126n person trade-off, 80�81 Global Burden of Disease, 81 standard gamble, 78 WTA.

Read the entire page →

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Index Pages 351-364

Index
Pages 351-364