Animal Food Labeling; Declaration of Certifiable Color Additives

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT for COLOR ADDITIVITES FINAL 5-9-12.doc Supporting Statement A	2012-05-09

IC Document Collections

IC ID	Document Title	Status
202341	Third Party Disclosure - 21 CFR 501.22(k)(2)	New
202340	Third Party Disclosure - 21 CFR 501.22(k)(1)	New

ICR Details

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
	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

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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.

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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 Name of Statute: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG02	Final or interim final rulemaking	76 FR 71248	11/17/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Third Party Disclosure - 21 CFR 501.22(k)(2)
Third Party Disclosure - 21 CFR 501.22(k)(1)

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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.

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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

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Common Form ICR:  No

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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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