翻译-美国临床试验资料接受度-FDA新法规造成的冲击冲击.pdf

Human Subject Protection; Acceptance of Data from Clinical Studies for Medical Devices;ProposedRule 2013 翻译作者：张汉东 AnalysisofEconomicImpacts FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates ReformAct of 1995(Public Law 104-4).Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety,andotheradvantages; distributiveimpacts; andequity).TheAgencybelieves that this proposed rule is not a significant regulatory action as defined by Executive Order 12866. FDA 已审查拟议的规则的影响下行政命令12866，1356 号行政命令，监管制 度的灵活性法 “（5 USC601-612），和资金的任务改革法案1995 （公法104-4）。 行政命令12866和1356 直接机构评估所有可用监管方案的成本和收益，监管是必 要时，要选择净效益最大化 （包括潜在的经济，环境，公众健康和安全，以及其 他优势;分配影响的监管办法，和股权）。该机构认为，这个建议的规则是不是行 政命令12866所定义的重大监管行动。 TheRegulatoryFlexibilityActrequiresAgenciestoanalyzeregulatoryoptionsthatwould minimize anysignificantimpactofaruleonsmallentities.Becausetherequirementsare likelyto impose aburden on a substantialnumber of affected small entities,the agency projectsthattheproposedrule, iffinalized,willhave asignificanteconomicimpactona substantialnumber of small entities, andhas conducted an Initial Regulatory Flexibility AnalysisasrequiredundertheRegulatoryFlexibilityAct. 如果法案通過的話將會對小公司造成巨大的衝擊. 灵活监管法要求监管机构分析选项，将最大限度地减少任何重大影响小实体规 则。由于要求都可能造成负担相当数量的受影响的小实体，机构，拟议的规则， 如果最终确定，将有一个显着的经济影响相当数量的小实体的项目，并进行了初 步的监管制度的灵活性灵活监管法所规定的分析。 Section 202(a) of the Unfunded Mandates Reform Act of 1995requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits,beforeproposing anyrulethatincludesanyFederalmandatethatmayresultin theexpenditureby State,local,andtribalgovernments,intheaggregate,orbyt