Fed Regist. 2003 Aug 27;68(166):51492-9.
The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), Public Law 108-20, 117 Stat. 638, authorized the Secretary of Health and Human Services (the Secretary), through the establishment of the Smallpox Vaccine Injury Compensation Program (the Program), to provide benefits and/or compensation to certain persons who have sustained injuries as a result of the administration of smallpox covered countermeasures (including the smallpox vaccine) or as a result of vaccinia contracted through accidental vaccinia inoculations. The SEPPA directed the Secretary to establish, by interim final rule, a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. As mandated by law, the Secretary is establishing such a Smallpox (Vaccinia) Vaccine Injury Table (the Table) through this interim final rule. The Secretary is also establishing a set of Table Definitions and Requirements, which define the terms and conditions included on the Table and are to be read in conjunction with the Table. The Secretary is seeking public comment on the Table established through this interim final rule. At a later date, the Secretary will publish a companion final rule setting forth the administrative implementation of the Program. The public will then be afforded an additional opportunity to comment on the procedures set forth therein.
2003年《天花应急人员保护法》(SEPPA),公法第108 - 20号,第117号法规第638条,授权卫生与公众服务部部长(部长)通过设立天花疫苗伤害赔偿计划(该计划),向因接种天花涵盖应对措施(包括天花疫苗)或因意外接种痘苗而感染痘苗病毒而遭受伤害的某些人员提供福利和/或赔偿。《天花应急人员保护法》指示部长通过暂行最终规则制定一份表格,列出应被推定因接种或接触天花疫苗而导致的不良反应(包括伤害、残疾、病症和死亡),以及每种列出的伤害的首次症状或表现必须出现的时间间隔,以便适用该推定。根据法律规定,部长通过本暂行最终规则制定这样一份天花(痘苗)疫苗伤害表格(该表格)。部长还制定了一套表格定义和要求,对表格中包含的术语和条件进行定义,并应与表格一并阅读。部长正在就通过本暂行最终规则制定的表格征求公众意见。稍后,部长将发布一份配套最终规则,阐述该计划的行政实施细则。届时,公众将有额外机会就其中规定的程序发表意见。