Food additives; Food Contact Substances Notification System

ICR 200005-0910-002

OMB: 0910-0444

Federal Form Document

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ICR Details
0910-0444 200005-0910-002
Historical Active
Food additives; Food Contact Substances Notification System
New collection (Request for a new OMB Control Number)   No
Approved without change 08/02/2000
Retrieve Notice of Action (NOA) 05/30/2000
Approved consistent with change and clarifications described in FDA memos of 7-24-00 and 8-2-00. FDA will submit any changes resulting from their current rulemaking on food contact substances to OMB for approval in conjunction with promulgation of that rule.
  Inventory as of this Action Requested Previously Approved
08/31/2003 08/31/2003
416 0 0
34,100 0 0
0 0 0

The Food and Drug Administration (FDA) is proposing regulations to implement the premarket notification process for food contact substances (FCSs) established by section 309 of Food and Drug Administration Modernization Act (FDAMA) of 1997 (Pub. L. 105-115). Once implemented, the notification process will be the primary method for authorizing new uses of food additives that are FCSs. FDA is proposing regulations that 1) identify the circumstances under which a food additive petition will be required to authorize the use of an FCS, 2) specify the information required in a notification for an FCS, 3) describe...



IC Title Form No. Form Name
Food additives; Food Contact Substances Notification System FDA-3480

  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 416 0 0 416 0 0
Annual Time Burden (Hours) 34,100 0 0 34,100 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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.

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