Food additives; Threshold of Regulation for Substances Used in Food-Contact Articles

ICR 200012-0910-003

OMB: 0910-0298

Federal Form Document

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Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0298 200012-0910-003
Historical Active 199712-0910-007
HHS/FDA
Food additives; Threshold of Regulation for Substances Used in Food-Contact Articles
Extension without change of a currently approved collection   No
Regular
Approved without change 02/02/2001
Retrieve Notice of Action (NOA) 12/22/2000
  Inventory as of this Action Requested Previously Approved
03/31/2004 03/31/2004 03/31/2001
6 0 60
288 0 3,200
0 0 0

In the Federal Register of July 17, 1995 (60 FR36582), the agency published a final rule (21 CFR 170.39; effective August 16, 1995) that established a process for determining when the liklihood or extent of migration to food of a substance used in a food-contact article is so trivial as not to require that it be the subject of a food additive listing regulation. Under this process, those materials whose use in food-contact articles results in dietary concentrations at or below the threshold level (1% of the acceptable daily intake for regulated direct food additives and 0.5 ppb for all other substances, as determined by FDA;...

None
None


No

1
IC Title Form No. Form Name
Food additives; Threshold of Regulation for Substances Used in Food-Contact Articles

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 6 60 0 0 -54 0
Annual Time Burden (Hours) 288 3,200 0 0 -2,912 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

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.
12/22/2000


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