[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.15]
 
[Page 341]
 
                        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. 71.15  Confidentiality of data and information in color additive petitions.
 
    (a) The following data and information in a color additive petition
are available for public disclosure, unless extraordinary circumstances
are shown, after the notice of filing of the petition is published in
the Federal Register or, if the petition is not promptly filed because
of deficiencies in it, after the petitioner is informed that it will not
be filed because of the deficiencies involved:
    (1) All safety and functionality data and information submitted with
or incorporated by reference in the petition.
    (2) A protocol for a test or study, unless it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in Sec. 20.61 of this chapter.
    (3) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information, after deletion of:
    (i) Names and any information that would identify the person using
the product.
    (ii) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
    (4) A list of all ingredients contained in a color additive, whether
or not it is in descending order of predominance. A particular
ingredient or group of ingredients shall be deleted from any such list
prior to public disclosure if it is shown to fall within the exemption
established in Sec. 20.61 of this chapter, and a notation shall be made
that any such ingredient list is incomplete.
    (5) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is shown to fall within the
exemption established in Sec. 20.61 of this chapter.
    (6) All records showing the Food and Drug Administration's testing
of or action on a particular lot of a certifiable color additive.
    (b) The following data and information in a color additive petition
are not available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or they
relate to a product or ingredient that has been abandoned and they no
longer represent a trade secret or confidential commercial or financial
information as defined in Sec. 20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control
procedures.
    (2) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.
    (c) All correspondence and written summaries of oral discussions
relating to a color additive petition are available for public
disclosure in accordance with the provisions of part 20 of this chapter
when the color additive regulation is published in the Federal Register.
    (d) For purposes of this regulation, safety and functionality data
include all studies and tests of a color additive on animals and humans
and all studies and tests on a color additive for identity, stability,
purity, potency, performance, and usefulness.
 
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