21 CFR 170.102 - Confidentiality of information in a premarket notification for a food contact substance (FCN).

§ 170.102 Confidentiality of information in a premarket notification for a food contact substance (FCN).

(a) During the 120-day period of the Food and Drug Administration (FDA) review of an FCN, FDA will not disclose publicly any information in that FCN.

(b) FDA will not disclose publicly the information in an FCN that is withdrawn prior to the completion of FDA's review.

(c) Once FDA completes its review of an FCN, the agency will make its conclusion about the FCN publicly available. For example, if FDA objects to a notification 90 days after the date of receipt, the agency would make available its objection at that time.

(d) By submitting an FCN to FDA, the manufacturer or supplier waives any claim to confidentiality of the information required to adequately describe the food contact substance and the intended conditions of use that are the subject of that FCN.

(e) The following data and information in an FCN are available for public disclosure, unless extraordinary circumstances are shown, on the 121st day after receipt of the notification by FDA, except that no data or information are available for public disclosure if the FCN is withdrawn under § 170.103.

(1) All safety and functionality data and information submitted with or incorporated by reference into the notification. Safety and functionality data include all studies and tests of a food contact substance on animals and humans and all studies and tests on a food contact substance for establishing identity, stability, purity, potency, performance, and usefulness.

(2) A protocol for a test or study, unless it is exempt from disclosure under § 20.61 of this chapter.

(3) A list of all ingredients contained in a food contact substance, excluding information that is exempt from disclosure under § 20.61 of this chapter. Where applicable, an ingredient list will be identified as incomplete.

(4) An assay method or other analytical method, unless it serves no regulatory or compliance purpose and is exempt from disclosure under § 20.61 of this chapter.

(5) All correspondence and written summaries of oral discussions relating to the notification, except information that is exempt for disclosure under § 20.61 of this chapter.

(6) All other information not subject to an exemption from disclosure under subpart D of part 20 of this chapter.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 170 after this date.

  • 2017-05-04; vol. 82 # 85 - Thursday, May 4, 2017
    1. 82 FR 20847 - Natural Resources Defense Council et al.; Denial of Food Additive Petition
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; denial of petition.
      This notification is effective May 4, 2017; except as to any provisions that may be stayed by the filing of proper objections. See Section VI of this document for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by June 5, 2017. Late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of June 5, 2017. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
      21 CFR Parts 170, 177, and 189
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