Animal Feed Regulatory Program Standards

Forms and Documents

Document Name	Status
0910-0760 SUPPORTING STATEMENT FINAL 12-9-2016.doc Supporting Statement A	2016-12-09

IC Document Collections

IC ID	Document Title	Status
209610	State Feed Regulatory Programs Other-Animal Feed Regulatory Program Standards	Modified

ICR Details

OMB Control No: 0910-0760	ICR Reference No: 201612-0910-003
Status: Historical Active	Previous ICR Reference No: 201404-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Animal Feed Regulatory Program Standards
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: 02/01/2017
	Date Received in OIRA: 12/30/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	36 Months From Approved	01/31/2017
Responses	40	0	50
Time Burden (Hours)	120,000	0	150,000
Cost Burden (Dollars)	0	0	0

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Abstract: The elements of the animal feed regulatory program standards are intended to ensure that the States have the best practices of a high-quality regulatory program to use for self-assessment and continuous improvement and innovation. The eleven standards describe the critical elements of a regulatory program designed to protect the safety and integrity of the U.S. animal feed supply. The standards include the following: 1) regulatory foundation; 2) training; 3) inspection program; 4) auditing; 5) feed-related illness or death and emergency response; 6) enforcement program; 7) outreach activities; 8) budget and planning; 9) assessment and improvement; 10) laboratory services; and 11) sampling program. Each standard has corresponding self-assessment worksheets, and certain standards have supplemental worksheets and forms that will assist State programs in determining their level of conformance with the standard. FDA will use the program standards as a tool to improve contracts with State agencies. The program standards will assist both FDA and the States in fulfilling their regulatory obligations.

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Authorizing Statute(s): PL: Pub.L. 111 - 353 205(c)(1) Name of Law: FSMA
   PL: Pub.L. 111 - 353 201 Name of Law: Food Safety Modernization 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:
	81 FR 21578	04/12/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 89947	12/13/2016
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
State Feed Regulatory Programs

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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	40	50	0	0	-10	0
Annual Time Burden (Hours)	120,000	150,000	0	0	-30,000	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: In 2014, this ICR was approved for a burden of 150,000 hours. This was calculated based on 50 respondents (50 States) with an average of 3,000 recordkeeping hours for each. Since then, FDA has enrolled 40 States in the program, with the average recordkeeping burden remaining the same. This change accounts for the decrease in the "Number of Recordkeepers" and "Total Hours" (120,000) shown in Table 1.

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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]? 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

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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: 12/30/2016

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