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§71.2 著色劑申請歸檔通知(Notice of filing of petition)

   2011-09-01 中國食品網(wǎng)中食網(wǎng)9340

      更多關(guān)于著色劑使用申請的法規(guī),請詳見美國FDA 21 CFR 第71部分關(guān)于著色劑使用申請的法規(guī)匯總

  § 71.2   Notice of filing of petition.

 ?。╝) 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.

 ?。╞) 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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