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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, 277278 Administrative Procedure Act (APA) , 21 American Petroleum Institute v.
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From page 352... ...
, 14, 7, 1012, of cost-effectiveness, 3637 1522, 2759, 64, 67, 129134, of health gains, 149151 143146, 151, 157, 168174, 178 Carter, Jimmy, 22 182, 188189, 194, 197, 204, 214, Case study analytic approach, 193244 217, 229, 238, 241, 269272, 292, conclusion, 240241 300, 318 EPA's nonroad engine air emissions calculation of net benefits, 31 regulation, 228240 valuation approach, 2930 FDA's juice processing regulation, 204 Benefit point transfer, 289 215 Benefits, 4, 318 general approach, 195203 Benefits analysis guidelines, 5155 NHTSA estimates of annual quantified monetized health-adjusted life years in benefits, 218 NHTSA's child restraints regulation, benefitcost analysis, 53 OMB criteria for evaluating stated 215228 purpose and scope, 193195 preference studies, 54 Benefits and costs Case study process, 196 ancillary benefits and countervailing Category rating (CR) , 7781, 98 risks, 289290 CDS.
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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, 1314 Convergent validity, 318 recommendation 10, 13 Correlations, 318 recommendation 11, 13 and conversions among HRQL recommendation 12, 1314 measures, 123124 Committee on Estimating the Health-Risk and cross-walks of HRQL measures, Reduction Benefits of Proposed Air 126127 Pollution Regulations, 18 Corrosion Proof Fittings v. EPA, 45 Committee on Summary Measures of Cost, 319 Population Health, 18 Cost-effectiveness analysis (CEA)
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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, 7980 Criteria for selecting HALY metrics for Direct uses of market data, 283284 regulatory CEA, 6872 Disability, defined, 319 standard performance criteria for HRQL Disability-adjusted life year (DALY) , 8081, instruments, 70 8891, 319 Criterion validity, 319 the WHO's DALY, 89 Cryptosporidium parvum, 204210 Disaggregated impacts, 176177 Current practices for regulatory analysis, Disclosure, full, 314 5065 Discount rates, 296303 benefits analysis guidelines, 5155 intergenerational discounting, 301302 current valuation practices, 5562 the rationale for discounting, 297298 key analytic requirements of OMB real discount rates of 3 percent and 7 guidelines, 51 percent, 298300 other guidelines relavant to CEA, 6265 social, 323 Current valuation practices, 5562 time preference for health-related EPA's morbidity inclusive life year benefits and costs, 300301 (MILY)
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From page 355... ...
See EuroQoL-5D and number of attribute levels for Equivalent lives saved (ELS) , 60, 215217, generic HRQL indexes, 95 273 Double-counting issues, 30, 62 Escherichia coli O157:H7, 204210 Estimates of QALY gains, 207212, 223 228, 233237 E HRQL with illness at average age of incidence, 235 Economic analysis, the role of, 1926 HRQL with injury, 227 Economic efficiency, 319320 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, 1011, 121 272273 Estimation of costs, 6263 Effectiveness metric, for public health and Estimation of "with condition" HRQL, safety rulemakings, 272274 198199 ELS.
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From page 356... ...
, 103, 198, Expert assignment of health states, using 215, 222226, 254257 generic HRQL instruments, 110111 Functional status, 74, 320 Externality, common property resource and Future generations in CEA, 152154 public good, 262263 discounting and timing of impacts, 153 "Extra-welfarists," 27
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From page 357... ...
, 129, 133137, 148150, 156, 160 199 170, 177189, 195209, 214218, Center for Risk Analysis, 117 222, 227, 232241, 273, 320 Health-adjusted life years (HALYs) , 210, with illness at average age of incidence, 1519, 2728, 3240, 5256, 6391, 235 122, 135, 159163, 181, 320 with injury, 227 alternative HALY metrics for regulatory measurement and regulatory CEA, CEA, 8691 conducting research to improve, 13 describing health states, 7476 14
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From page 358... ...
See International Classification of 102106 Disease codes generic HRQL indexes, 93102 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, 9293 on small businesses and other small uncertainty in health status and entities, 310311 preference measurement, 121123 Indirect uses of market data, 284285 Health states, 74, 320 Individual preferences, and societal values, changes in, 136 138139 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, 7476 making, 1213, 181184 health-adjusted life years, 75 distributional and other aspects of risk "postregulatory," 8 and regulation, 183 Health Utilities Index (HUI)
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From page 359... ...
See Intrarater test 6061, 216218, 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)
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From page 360... ...
, 126n 279, 313315 National Research Council Circular A-4, 3, 16, 23, 40, 50, 5356, Board on Environmental Studies and 6265, 134, 146, 152154, 174, Toxicology, 121 194196, 217, 258315 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.
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From page 361... ...
See Particulate matter emissions total losses, 210, 224, 236 Population-based, condition-specific HRQL Quality of Life Instruments Database, 102n values, 112113 Quality of Well-Being Scale (QWB) , 6, 58 Population health data, and subgroups, 59, 7172, 9798, 114, 122, 165 148149 166, 198204, 212215, 222227, Population survey data-based approaches, 245246 110116 availability, 98 catalogues of chronic condition HRQL domains, 98 values, 111113 history, 9798 incorporation of health profiles and self-administered version, 98 HRQL questions and instruments in valuation, 98 routine population surveys, 114116 Quantified benefits, 313 sources for population-based, condition EPA estimates of annual, 230 specific HRQL values, 112113 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.
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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 "Riskrisk" analysis, 49 revisability and appeals, 157 Risks Regulatory development with delayed effects, 142 and economic analysis, 34 detecting, 141142, 145 key requirements of the Administrative dimensions of value affecting the Procedure Act, 21 acceptability of, 140143 process of, 2022 and dread, 142, 145 requirements for regulatory analysis and personal control over, 142, 145 decision making, 2226 treatment of, 314 the role of economic analysis in, 1926 Routine population surveys, incorporation Regulatory Flexiblity Act, 267, 310 of health profiles and HRQL "Regulatory flexiblity analysis" (RFA) , questions and instruments in, 114 310311 116 Regulatory interventions, 10 RS.
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From page 363... ...
See Toxic Substances Control Act "Social rate of time preference," 299 TTO. See Time trade-off Special populations, 104105 TTO method and discounting, 84 Specialized analytical requirements, 310 313 analysis of unfunded mandates, 311 U energy impacts, 312313 environmental impact statements, 312 Uncertain outcomes, economic values of, impact on small businesses and other 310 small entities, 310311 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, 311312 310 SPM.
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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, 7786 202203, 211 comparisons among elicitation methods, "Without condition" values, 234 8186 "Without pathogen-related illness," 215 direct rating -- category rating and visual World Health Organization (WHO) , 8789, analogue scales, 7980 126n person trade-off, 8081 Global Burden of Disease, 81 standard gamble, 78 WTA.
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