[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.102]

[Page 22-23]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 170_FOOD ADDITIVES--Table of Contents
 
                    Subpart D_Premarket Notifications
 
Sec.  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withdrawn prior to the completion of FDA's review.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.

[[Page 23]]

    (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withdrawn under Sec.  170.103.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 Sec.  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 Sec.  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 
Sec.  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 Sec.  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.