[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.2]
[Page 334]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 71 COLOR ADDITIVE PETITIONS--Table of Contents
Subpart A General Provisions
Sec. 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 Sec. 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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