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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:
0910-0721
ICR Reference No:
201205-0910-006
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Animal Food Labeling; Declaration of Certifiable Color Additives
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/27/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/17/2012
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is approved. The agency should note, however, that OMB is not allowing them to attribute a program change to a statute that is more than twenty years old.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2015
11/30/2013
Responses
15,458
0
0
Time Burden (Hours)
3,865
0
0
Cost Burden (Dollars)
4,608,153
0
0
Abstract:
Under the provisions of the Nutrition Labeling and Education Act (the 1990 amendments), producers are required, among other things, to list on food labels all of the common or usual names of all color additves required to be certified by FDA.
Authorizing Statute(s):
US Code:
21 USC 321(f)
Name of Law: FD&C Act
Citations for New Statutory Requirements:
Statute at Large: 21 Stat. 321
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG02
Final or interim final rulemaking
76 FR 71248
11/17/2011
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Third Party Disclosure - 21 CFR 501.22(k)(1)
Third Party Disclosure - 21 CFR 501.22(k)(2)
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
15,458
0
0
15,458
0
0
Annual Time Burden (Hours)
3,865
0
0
3,865
0
0
Annual Cost Burden (Dollars)
4,608,153
0
0
4,608,153
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Program change (increase) due to final rule in response to the Nutrition Labeling and Education Act (the 1990 amendments). In addition, due to the time lapse for submission of final rule, OMB was consulted and concluded that the paperwork for the final rule could be submitted at this time.
Annual Cost to Federal Government:
$1,076
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:
Denver Presley 3018271462
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:
05/17/2012
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