[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: 21CFR71.4]
[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. 71.4 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petition will be considered withdrawn without prejudice.
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