[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR171.6]

[Page 28]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 171_FOOD ADDITIVE PETITIONS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 171.6  Amendment of petition.

    After a petition has been filed, the petitioner may submit 
additional information or data in support thereof. In such cases, if the 
Commissioner determines that the additional information or data amount 
to a substantive amendment, the petition as amended will be given a new 
filing date, and the time limitation will begin to run anew. If 
nonclinical laboratory studies are involved, additional information and 
data submitted in support of filed petitions shall include, with respect 
to each nonclinical study, either a statement that the study was 
conducted in compliance with the requirements set forth in part 58 of 
this chapter, or, if the study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance.

[50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985]

[[Page 29]]