Substances Prohibited From Use in Animal Food or Feed - 21 CFR Part 589

Forms and Documents

Document	Type	Status	Availability
SS-BSE_No.0910-0627.doc	Supporting Statement A	Uploaded 2011-10-19	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
185751	Substances Prohibited From Use in Animal Food or Feed - 21 CFR Part 589		Modified

ICR Details

OMB Control No: 0910-0627	ICR Reference No: 201110-0910-008
Status: Historical Active	Previous ICR Reference No: 200807-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Substances Prohibited From Use in Animal Food or Feed - 21 CFR Part 589
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/30/2012
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/20/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved
Responses	175	0	0
Time Burden (Hours)	10,114	0	0
Cost Burden (Dollars)	200,707	0	0

---

Abstract: This is a request for OMB approval of the following information collection requirements: 21 CFR 589.2001 (c)(2)(ii) and (vi)- Recordkeeping, 21 CFR 589.2001 (c)(3)(i) - Recordkeeping 21 CFR 589.2001(c)(3)(i) (a) and (b) - Recordkeeping, 21 CFR 589.2001(b)(1) and 21 CFR 589.2001(f)-- Reporting-- New requirement that any foreign country seeking a designation from FDA that such country, due to a low BSE risk in that country, is not subject to the restrictions applicable to cattle materials prohibited in animal feed must submit a written request to the agency. The written request would have to include sufficient scientific evidence to support the claimed BSE risk status. These records will be subject to inspection by Federal and State agencies to ensure that animal food or feed does not contain protein which may cause the spread of BSE in this country.

---

Authorizing Statute(s): US Code: 21 USC 342 (a)(5)
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 45259	07/28/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 64950	10/19/2011
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Substances Prohibited From Use in Animal Food or Feed - 21 CFR Part 589

---

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	175	0	0	0	0	175
Annual Time Burden (Hours)	10,114	0	0	0	0	10,114
Annual Cost Burden (Dollars)	200,707	0	0	0	0	200,707

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:

---

Annual Cost to Federal Government: $25,000

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

---

Common Form ICR:  No

---

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: 10/20/2011

---