In accordance with 5 CFR 1320, the information collection is approved for three years. In its next request, FDA should provide an electronic option for submitting this information, provide a timeline for completing an electronic option for submission, or explain why an electronic option is not appropriate.
Inventory as of this Action
Requested
Previously Approved
10/31/2013
36 Months From Approved
10/31/2010
7
0
15
336
0
720
0
0
0
Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(a)), the use of a food additive is deemed unsafe unless one of the following is applicable: (1) It conforms to an exemption for investigational use under section 409(j) of the act, (2) it conforms to the terms of a regulation prescribing its use, or (3) in the case of a food additive which meets the definition of a food-contact substance in section 409(h)(6) of the act, there is either a regulation authorizing its use in accordance with section 409(a)(3)(A) or an effective notification in accordance with section 409(a)(3)(B). The regulations in 21 CFR 170.39 established a process that provides the manufacturer with an opportunity to demonstrate that the likelihood or extent of migration to food of a substance used in a food-contact article is so trivial that the use need not be the subject of a food additive listing regulation or an effective notification. The agency has established two thresholds for the regulation of substances used in food contact articles. The first exempts those substances used in food-contact articles where the resulting dietary concentration would be at or below 0.5 part per billion (ppb). the second exempts regulateddirect food additives for use in food - contact articles where the resulting dietary exposure is 1 percent or less of the acceptable daily intake for these substances. In order to determine whether the intended use of a substance in a food-contact article meets the threshold criteria, certain information specified in 21 CFR 170.39 ( c ) must be submitted to FDA.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
SS-0910-0298.doc
Food Additives; Threshold of Regulation for Substances Used in Food-Contact Articles