Additives in Animal Food

Forms and Documents

Document Name	Status
0546 Animal Food Food-Additives SSA 2025 REV.docx Supporting Statement A	2025-05-05
83-C for 0546 to add info to ROCIS 9-05-23.docx Justification for No Material/Nonsubstantive Change	2023-09-06

IC Document Collections

IC ID	Document Title	Status
6266	Moderate Category - Non-Complex Food Additive Petitions Other-Legislative Authority	Modified
251111	Labeling of Color Additive or Lake of Color Additive; Labeling of Color Additives Not Subject to Certification Other-Legislative Authority	Modified
206417	Complex Category - Investigational Food Additive Files	Unchanged
206416	Moderate Category - Investigational Food Additive Files	Unchanged
191904	Amendment of Petitions	Unchanged
191903	Complex Category- Complex Food Additive Petitions	Unchanged

ICR Details

OMB Control No: 0910-0546	ICR Reference No: 202411-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202308-0910-022
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Additives in Animal Food
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/16/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	2,616	0
Time Burden (Hours)	119,147	0
Cost Burden (Dollars)	0	0

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Abstract: The information collections supports implementation of FDA requirements applicable to animal food food-additives as established in 21 CFR 570 and 571. Respondents to the information collection are sponsors of products for use in animal food.

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Authorizing Statute(s): US Code: 21 USC 409(a) and (b) Name of Law: Federal Food, Drug and Cosmetic Act
   US Code: 21 USC 343(i) Name of Law: Federal Food, Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

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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:
	89 FR 103838	12/19/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 18660	05/01/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Amendment of Petitions
Complex Category - Investigational Food Additive Files
Complex Category- Complex Food Additive Petitions
Labeling of Color Additive or Lake of Color Additive; Labeling of Color Additives Not Subject to Certification
Moderate Category - Investigational Food Additive Files
Moderate Category - Non-Complex Food Additive Petitions

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ICR Summary of Burden

	Total Request	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	2,616	0	0	2,616	0	0
Annual Time Burden (Hours)	119,147	0	0	119,147	0	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: The information collection includes program changes and adjustment. We have revised the scope of activity to include recommendations found in agency guidance pertaining to consultations. After including consultation activities in our assessment of burden, we have increased our estimate by 40,600 total hours and 24 responses, annually. We have also modified the title of the information collection.

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Annual Cost to Federal Government: $54,253

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 05/16/2025

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