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

Forms and Documents

Document Name	Status
SS-BSE Comment No.0910-0589 #2.doc Supporting Statement A	2008-07-11

IC Document Collections

IC ID	Document Title	Status
185751	Substances Prohibited From Use in Animal Food or Feed; Final Rule - 21 CFR Part 589	New

ICR Details

OMB Control No: 0910-0627	ICR Reference No: 200807-0910-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Substances Prohibited From Use in Animal Food or Feed; Final Rule - 21 CFR Part 589
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/29/2008
	Date Received in OIRA: 07/18/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2011	36 Months From Approved
Responses	175	0	0
Time Burden (Hours)	10,114	0	0
Cost Burden (Dollars)	200,707	0	0

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Abstract: Regulations for this final rule, among other things requires that written procedures be developed and maintained to ensure separation of mammalian protein intended for use in all animal feed. Also requires recordkeeping to ensure that prohibited bovine materials are not included in animal feed.

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Authorizing Statute(s): US Code: 21 USC 342 (a)(5) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AF46	Final or interim final rulemaking	73 FR 22720	04/25/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	70 FR 58569	10/06/2005
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 22720	04/25/2008
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
Substances Prohibited From Use in Animal Food or Feed; Final Rule - 21 CFR Part 589

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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection. Sections 21CFR 589.2001(b)(1) and 21 CFR 589.2001(f)(reporting requirements) were added at the final rule stage.

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Annual Cost to Federal Government: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 07/18/2008

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