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§71.2 着色剂申请归档通知(Notice of filing of petition)
2011-09-01 09:53  点击:3321
发布单位:FDA
发布文号:64 FR 400
发布日期:1999-01-05
生效日期:暂无
有效性状态:
废止日期:暂无
备注:受理专员在着色剂申请提交15日之内会通知申请人其申请是否被受理(申请书中含有一种新药物的除外),没有被受理的则会提供未被受理的原因,在申请提交之日起30日内受理专员在联邦注册上会刊登申请人的姓名、申请简要,同时当原始文件签署时将通知复印件邮寄给申请人。

      更多关于着色剂使用申请的法规,请详见美国FDA 21 CFR 第71部分关于着色剂使用申请的法规汇总

  § 71.2   Notice of filing of petition.

  (a) Except where the petition involves a new drug, the Commissioner, within 15 days after receipt, will notify the petitioner of acceptance or nonacceptance of a petition, and if not accepted the reasons therefor. If accepted, the date of the notification letter sent to petitioner becomes the date of filing for the purposes of section 721(d)(1) of the act. If the petitioner desires, he may supplement a deficient petition after being notified regarding deficiencies. If the supplementary material or explanation of the petition is deemed acceptable, petitioner shall be notified. The date of such notification becomes the date of filing. If the petitioner does not wish to supplement or explain the petition and requests in writing that it be filed as submitted, the petition shall be filed and the petitioner so notified. The date of such notification becomes the date of filing. Where the petition involves a new drug, notification to the petitioner will be made in accordance with §70.10(b)(3) of this chapter.

  (b) The Commissioner will cause to be published in the  Federal Register  within 30 days from the date of filing of such petition a notice of the filing, the name of the petitioner, and a brief description of the proposal in general terms. A copy of the notice will be mailed to the petitioner when the original document is signed.

  [42 FR 15639, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999]

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