Final regulatory impact analysis

U.S. Environmental Protection Agency, 1985. Costs and Benefits of Reducing Lead in Gasoline Final Regulatory Impact Analysis. 

NHTSA (2005b). Tire pressure monitoring system. FMVSS No. 138. Final regulatory impact analysis, March 2005. U.S. Department of Transportation, Washington DC (from Hauer, 2006). 

In October 1981 NHTSA published the final regulatory impact analysis upon which the rescission of mandatory passive (automatic) occupant restraints was based. The basic approach in anal is of the safety nefits and dollar costs is similar to that of earlier studies and some of the same data is used to make estimates. The text of the 1981 NHTSA document and the benefit-cost anal is found in Appendix A of the report permit comparison of... 

U. S. Department of Transportation. National Highway Traffic Safety Administration. Final Regulatory Impact Analysis Rescission of Automatic Occupant Protection Requirements. DOT HS 806 055. October 1981. 

Schwartz, J. and Otto, D. (1987). Blood lead, hearing thresholds, and neurobehavioral development in children and youth. Arch. Environ. Health, 42, 153-160 Schwartz, J., Pitcher, H., Levin, R., Ostro, B. and Nichols, A.L. (1985). Costs and benefits of reducing lead in gasoline final regulatory impact analysis. Washington, DC US Environmental Protection Agency, Office of Policy, Planning and Evaluation EPA report no. EPA-230/05-85-006. 

Under Section 9(f)(2), the Commission s final rule must be accompanied by a regulatory impact analysis which describes the potential costs and benefits associated with the rule, analyzes the costs and benefits of alternative approaches that the Commission has considered and rejected, and discusses all significant issues raised during the public comment period. Pursuant to Section 9(g)(1), the rule must specify an effective date which does not exceed 180 days from the rule s promulgation unless the Commission finds that a delayed effective date is in the public interest. 

Technical standards are issued through notice-and-comment rulemaking. After hazard identification and expert discussion, draft standards are published for public comments, which are considered in formulation of the final rule. Draft standards must be accompanied by a regulatory impact statement, including a cost-benefit analysis for standards involving substantial economic impact. 

A very important cultural difference between Europe and the United States, that impacts on drug development, is indirectly expressed at the stage when the regulatory authority examines the final submitted dossier. In the United States, the FDA adopts a bottom-up stance, in which it looks at the basic raw data and sees what conclusions can be drawn from it, using its own criteria for analysis and interpretation. In Europe, the authorities tend to take the opposite approach they look at the conclusions of all the studies, as manifested... 

If research is to be used for regulatory approval of a drug, the International Conference on Harmonization (ICH) guidelines that have been adopted by Canada must be followed. Budgets must be evaluated to ensure no conflicts of interest exist. Placebo-controlled studies are not considered acceptable when effective standard therapies or interventions are available. Investigators must inform subjects as to why placebos are necessary when used, and, if any treatment is to be withdrawn and the associated impact. Although sponsors may obtain preliminary data for analysis, final analysis and interpretation should be by the researchers to ensure the accuracy and integrity of the work. 

Finally, we could not ignore another area in which the regulatory authorities have had a major impact on pharmaceutical analysis in the pharmaceutical industry. Our concluding chapter deals with process validation as it applies to pharmaceutical analysis. 

Finally, an analysis of the impact of the change on any filed regulatory documents is necessary, as well as informing the pharmaceutical users of the API. Pharmaceutical manufacturers might have additional quality and performance criteria, which are unknown to the API manufacturer, and these criteria need to he assessed relative to the process change under review. 

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