Cattle Materials Prohibited From Use in Animal Food or Feed

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0627 BSE Supporting Statement 03-27-2024 Clean.docx	Supporting Statement A	Uploaded 2024-03-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
261486	Cattle Materials Prohibited From Use in Animal Food or Feed; Reporting		New
185751	Cattle Materials Prohibited from Use in Animal Food or Feed; Recordkeeping		Modified

ICR Details

OMB Control No: 0910-0627	ICR Reference No: 202308-0910-008
Status: Active	Previous ICR Reference No: 202103-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Cattle Materials Prohibited From Use in Animal Food or Feed
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/29/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/28/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2027	36 Months From Approved	05/31/2024
Responses	147	0	175
Time Burden (Hours)	6,591	0	9,156
Cost Burden (Dollars)	0	0	0

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Abstract: This collection requires respondents to keep specific records as identified in 21 CFR part 589 and establishes reporting provisions for those respondents seeking to be designated as not subject to specific restrictions as stated in the regulations. The information collection supports regulatory measures that will help FDA prevent BSE from infiltrating animal food or feed. Respondents to this information collection are foreign governments seeking designation under §â€‰589.2001(f) and private sector rendering facilities that process cattle materials under §â€‰589.2001(c).

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Authorizing Statute(s): US Code: 21 USC 342 (a)(5) 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:
	88 FR 70676	10/12/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 21257	03/27/2024
Did the Agency receive public comments on this ICR? Yes

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

table that charts list of burden

IC Title	Form No.	Form Name
Cattle Materials Prohibited From Use in Animal Food or Feed; Reporting
Cattle Materials Prohibited from Use in Animal Food or Feed; Recordkeeping

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ICR Summary of Burden

table that charts list 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	147	175	0	0	-28	0
Annual Time Burden (Hours)	6,591	9,156	0	0	-2,565	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 our review since the last OMB approval, there is an overall adjustment decrease of 2,565 burden hours. The adjustment is attributable to decreases in the average reporting burden time and in respondents subject to recordkeeping requirements.

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Annual Cost to Federal Government: $2,184

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: 03/28/2024

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