[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.2]

[Page 361-362]
 
                        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

[[Page 362]]

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]