Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225

Forms and Documents

Document Name	Status
Medicated Feed Supporting Statement A.doc Supporting Statement A	2011-02-07

IC Document Collections

IC ID	Document Title	Status
5764	Registered Licensed Commercial Feed Mills	Modified
196299	Nonregistered Unlicensed Mixer-Feeders	New
196298	Nonregistered Unlicensed Commercial Feed Mills	New
196297	Registered Licensed Mixer-Feeders	New

ICR Details

OMB Control No: 0910-0152	ICR Reference No: 201102-0910-003
Status: Historical Inactive	Previous ICR Reference No: 200712-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 04/25/2011
	Date Received in OIRA: 02/16/2011
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB considers this ICR to be improperly submitted. OMB notes that there is an adjustment decrease of 33,754,789 responses and 68,102 hours. These large decreases are not explained and so there is insufficient information to evaluate the collection. Please correct this and resubmit the request to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	06/30/2011
Responses	34,931,951	0	34,931,951
Time Burden (Hours)	7,206,902	0	7,206,902
Cost Burden (Dollars)	0	0	0

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Abstract: These recordkeeping requirements apply to medicated feeds produced by licensed and non-licensed feed manufacturers, both commercial feed mills and mixer-feeders. This information is needed so that FDA can monitor drug usage and possible mis-formulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled.

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Authorizing Statute(s): US Code: 21 USC 351 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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 73101	11/29/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 6620	02/03/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Registered Licensed Commercial Feed Mills
Registered Licensed Mixer-Feeders
Nonregistered Unlicensed Commercial Feed Mills
Nonregistered Unlicensed Mixer-Feeders

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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:

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Annual Cost to Federal Government: $27,649

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: 02/16/2011

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