Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

Forms and Documents

Document Name	Status
0339_Supporting Statement_2022.docx Supporting Statement A	2022-08-10

IC Document Collections

IC ID	Document Title	Status
5939	Written Procedures	Modified

ICR Details

OMB Control No: 0910-0339	ICR Reference No: 202204-0910-018
Status: Received in OIRA	Previous ICR Reference No: 201907-0910-020
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/11/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2022
Responses	225	320
Time Burden (Hours)	3,150	4,480
Cost Burden (Dollars)	0	0

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Abstract: The information collection requires renderers, feed manufacturers, and others involved in feed and feed ingredient manufacturing and distribution to maintain written procedures specifying the cleanout procedures or other means and specifying the procedures for separating products that contain or may contain protein derived from mammalian tissue from all other protein products from the time of receipt until the time of shipment. These written procedures are intended to help the firm formalize consistent processes, and then to help inspection personnel confirm that the firm is conducting these processes in compliance with the regulation.

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Authorizing Statute(s): US Code: 21 USC 371(a) 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:
	87 FR 4626	01/28/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 49596	08/11/2022
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Written Procedures

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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	225	320	0	0	-95	0
Annual Time Burden (Hours)	3,150	4,480	0	0	-1,330	0
Annual Cost Burden (Dollars)	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement: Based on a review of the information collection since our last request for OMB approval we have adjusted our burden estimate, which has resulted in a decrease of 1,330 burden hours. Review of our inspection data suggests that the number of facilities that need to conduct these separation practices is gradually decreasing, therefore we have decreased the number of facilities who must comply, as well as the total number of hours needed to comply with this burden.

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Annual Cost to Federal Government: $16,785

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.     No

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: 08/11/2022

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