§71.15 着色剂申请数据和信息的保密(Confidentiality of data and information in color additive petitions)

      更多关于着色剂使用申请的法规，请详见美国FDA 21 CFR 第71部分关于着色剂使用申请的法规汇总。

　　§ 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 §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 §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 §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public as defined in §20.81 of this chapter or they relate to a product or ingredient that has been abandoned and they no longer represent a trade secret or confidential commercial or financial information as defined in §20.61 of this chapter: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.