Animal Food Labeling; Declaration of Certifiable Color Additives

Forms and Documents

Document Name	Status
0721 SS Part A 2015.pdf Supporting Statement A	2015-07-16

IC Document Collections

IC ID	Document Title	Status
202341	Third Party Disclosure - 21 CFR 501.22(k)(2)	Removed
202340	Labeling of color additive or lake of color additive; labeling of color additives not subject to certification	Modified

ICR Details

OMB Control No: 0910-0721	ICR Reference No: 201507-0910-005
Status: Historical Active	Previous ICR Reference No: 201205-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Animal Food Labeling; Declaration of Certifiable Color Additives
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/28/2015
	Date Received in OIRA: 07/16/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2018	36 Months From Approved	08/31/2015
Responses	2,587	0	15,458
Time Burden (Hours)	647	0	3,865
Cost Burden (Dollars)	0	0	4,608,153

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Abstract: Under the provisions of the Nutrition Labeling and Education Act (the 1990 amendments), animal feed 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. This collection supports agency regulations requiring third-party disclosure of color additives in animal food labeling. Respondents to the collection are animal feed companies.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 17445	04/01/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 37269	06/30/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Labeling of color additive or lake of color additive; labeling of color additives not subject to certification
Third Party Disclosure - 21 CFR 501.22(k)(2)

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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	2,587	15,458	0	-12,871	0	0
Annual Time Burden (Hours)	647	3,865	0	-3,218	0	0
Annual Cost Burden (Dollars)	0	4,608,153	0	-4,608,153	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Implementation of regulation has been realized since initial ICR was established. The agency has now consolidated the two ICs into one. These changes are discussed more fully in the supporting statement at Q.12 and Q15.

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Annual Cost to Federal Government: $1,098

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: 07/16/2015

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