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§171.7 公正撤销申请(Withdrawal of petition without prejudice)

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放大字体缩小字体2011-04-09 03:58:19 来源:GPO 浏览次数9span id="hits">2704
核心提示:在某些情形下管理机构将通知申请人,称申请尽管在技术上是完整的,但仍不足以证明设定某个规章的合理性。做出这样的通知的原因可能是数据不够清晰或完整。在这样的情形下,申请人可以撤销申请而暂不对申请进行解释或获得额外数据。这项撤销并不损害未来的申请归档。申请人可在联邦公报公布之前的任何时间撤销申请、/div>
发布单位
FDA
FDA
发布文号 42 FR 14489
发布日期 1977-03-15 生效日期 暂无
有效性状?/th> 废止日期 暂无
备注 在某些情形下管理机构将通知申请人,称申请尽管在技术上是完整的,但仍不足以证明设定某个规章的合理性。做出这样的通知的原因可能是数据不够清晰或完整。在这样的情形下,申请人可以撤销申请而暂不对申请进行解释或获得额外数据。这项撤销并不损害未来的申请归档。申请人可在联邦公报公布之前的任何时间撤销申请、/td>

   171.7 Withdrawal of petition without prejudice.

  (a In some cases the Commissioner will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a regulation or the regulation requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal will be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling.

  (b At any time before the order provided for in 171.100(a has been forwarded to the Federal Register for publication, the petitioner may withdraw the petition without prejudice to a future filing. Upon refiling the time limitation will begin to run anew.

  (c Any petitioner who has a food additive petition pending before the agency and who subsequently submits a premarket notification for a food contact substance (FCN for a use or uses described in such petition shall be deemed to have withdrawn the petition for such use or uses without prejudice to a future filing on the date the FCN is received by the Food and Drug Administration.

  [42 FR 14489, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002]

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