[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.4]

[Page 339]
 
                        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. 71.4  Samples; additional information.

    The Commissioner may request samples of the color additive, articles 
used as components thereof, or of the food, drug, or cosmetic in which 
the color additive is proposed to be used, or which comprises the color 
additive, and any additional information needed to clarify a submitted 
method or other aspect of a petition at any time while a petition is 
under consideration. The Commissioner shall specify in the request for a 
sample of the color additive, or articles used as components thereof, or 
of the food, drug, or cosmetic in which the color additive is proposed 
to be used, or which comprises the color additive, a quantity deemed 
adequate to permit tests of analytical methods to determine quantities 
of the color additive present in products for which it is intended to be 
used or adequate for any study or investigation reasonably required with 
respect to the safety of the color additive or the physical or technical 
effect it produces. The date used for computing the 90-day limit for the 
purposes of section 721(d)(1) of the act shall be moved forward 1 day 
for each day, after mailing date of the request, taken by the petitioner 
to submit the information and/or sample. If the information or sample is 
requested a reasonable time in advance of the 180 days, but is not 
submitted within such 180 days after filing of the petition, the 
petition will be considered withdrawn without prejudice.