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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0495
ICR Reference No:
200812-0910-002
Status:
Historical Active
Previous ICR Reference No:
200606-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Food Additives; Food Contact Substances Notification System
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
05/26/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/10/2008
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2012
36 Months From Approved
05/31/2009
Responses
128
0
126
Time Burden (Hours)
37,975
0
15,985
Cost Burden (Dollars)
0
0
23,500,000
Abstract:
The Food and Drug Administration's regulations at 21 CFR 170.101 and 170.106 implement the premarket notification process for food contact substances (FCSs). The notification process is the primary method for authorizing new uses ofFCS. The regulations: 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 the administration of the notification process, and 4) establish the procedure by which the agency may deem a notification to no longer be effective.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
73 FR 50628
08/27/2008
30-day Notice:
Federal Register Citation:
Citation Date:
73 FR 73936
12/04/2008
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Food Additives; Food Contact Substances Notification System
Food Additives; Food Contact Substances Notification System
FDA 3479
Notification for a Food Contact Substance Formulation
Food Additives; Food Contact Substances Notification System
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System
Food Additives; Food Contact Substances Notification System
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
ICR Summary of Burden
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
128
126
0
0
2
0
Annual Time Burden (Hours)
37,975
15,985
0
0
21,990
0
Annual Cost Burden (Dollars)
0
23,500,000
0
0
-23,500,000
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$6,000,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/10/2008
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