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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:
201211-0910-009
Status:
Historical Active
Previous ICR Reference No:
200812-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Food Additives; Food Contact Substances Notification System
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/13/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/30/2012
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/29/2016
36 Months From Approved
02/28/2013
Responses
237
0
128
Time Burden (Hours)
27,035
0
37,975
Cost Burden (Dollars)
0
0
0
Abstract:
Food contact substances must be preapproved by FDA for marketing. Manufacturers must provide information, including: (1) the identity and intended use of the food contact substance and (2) the basis for the manufacturer's or supplier's determination that the food contact substance is safe. FDA uses the submitted information to determine whether a food contact substance should be preapproved.
Authorizing Statute(s):
US Code:
21 USC 348(h)
Name of Law: Notification relating to food contact substance.
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:
77 FR 19670
04/02/2012
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 34955
06/12/2012
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
21 CFR 170.1 Indirect Food Additives
21 CFR 170.101 (Category B)
FDA 3480
Food Contact Substance Notification
21 CFR 170.101 (Category C)
FDA 3480
Food Contact Substance Notification
21 CFR 170.101 (Category D)
FDA 3480
Food Contact Substance Notification
21 CFR 170.101 (Category E)
FDA 3480
Food Contact Substance Notification
21 CFR 170.106 (Category A)
FDA 3479
Notification for a Food Contact Substance Formulation
Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance)
FDA 3480A
Amendment to Existing Food Contact Notification Prenotification Consultation Food Master File
Prenotification Consultation or Master File (concerning a food contact substance)
FDA 3480
Food Contact Substance Notification
Use of Recycled Plastics in Food Packaging
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
237
128
0
110
-1
0
Annual Time Burden (Hours)
27,035
37,975
0
55
-10,995
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
A decrease of one annual response to this ICR resulted in a downward adjustment of 10,995 hours. Our recommended use of Form FDA 3480A resulted in a program change of an additional 110 responses and 55 hours.
Annual Cost to Federal Government:
$6,040,000
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]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
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:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
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:
11/30/2012
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