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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:
201208-0910-008
Status:
Historical Inactive
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:
Improperly submitted and continue
Conclusion Date:
11/05/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/30/2012
Terms of Clearance:
In accordance with 5CFR 1320, OMB considers this collection to have been improperly submitted. The supporting statement describes a program change that has been listed in ROCIS. In addition, the Abstract section describes the program as a whole, not the specific information being collected and its purpose. Please correct these issues and resubmit the collection to OMB.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2012
36 Months From Approved
02/28/2013
Responses
128
0
128
Time Burden (Hours)
37,975
0
37,975
Cost Burden (Dollars)
0
0
0
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):
US Code:
21 USC 348(h)
Name of Law: Food, Drug, and Cosmetic Act
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
Food Additives; Food Contact Substances Notification System Category A
FDA 3479
Notification for a Food Contact Substance Formulation
Food Additives; Food Contact Substances Notification System Category B
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Category C
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Category D
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Category E
FDA3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Indirect FAP
Food Additives; Food Contact Substances Notification System Prenotification Consult or MF
FDA Form 3480
NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System; Amendment
FDA Form 3480A
Amendment to an Existing FCN, Prenotification Consultation, Master File
Food Additives; Food Contact Substances Notification System; Food Packaging
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:
$6,400,000
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:
08/30/2012
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