发布时间:2013-10-01
FDA暂停2014年费征收及关闭注册数据库和付费数据库;恢复日期待公布
本次的美国政府停摆,也影响到了美国食品药品监督管理局(FDA)的部分工作的如期开展;食品和药物管理局系统中,近五成雇员将放假。继续上班的雇员中,超过七成依赖企业交纳的费用。
目前FDA在政府预算获批和恢复运作前,只继续运作以下针对紧急状况的相关部门和工作;其他所有业务部门和工作将在政府恢复运作后继续启动:
As of October 1 and continuing until the enactment of an FY 2014 appropriation or Continuing Resolution, FDA operations will be limited to the following:
o Emergency work involving the safety of human life or the protection of property;
o Criminal law enforcement work; and
o Activities funded by 2013 Medical Device User Fee carryover.
During this time, FDA will not have legal authority to accept 2014 user fees. This means that until operations resume, FDA will NOT collect any 2014 user fees and will NOT be able to accept any regulatory submissions for FY 2014 that require a fee payment.
FDA于
- 无法申请2014财年付款识别码和进行2014年度认证
- 无法更新现有注册信息
- 无法进行新公司和新产品的注册
IRC将在FDA恢复运作后及时启动FDA2014制造商年费的付款指导和通知,请关注相关信息。
IRC编译整理
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