[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: 21CFR71.15]

[Page 363-364]
 
                        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

[[Page 364]]

and tests on a color additive for identity, stability, purity, potency, 
performance, and usefulness.