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

ICR 201104-0910-010

OMB: 0910-0152

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-06-16
IC Document Collections
ICR Details
0910-0152 201104-0910-010
Historical Active 200712-0910-007
HHS/FDA
Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225
Extension without change of a currently approved collection   No
Regular
Approved with change 06/27/2011
Retrieve Notice of Action (NOA) 04/27/2011
  Inventory as of this Action Requested Previously Approved
06/30/2014 36 Months From Approved 06/30/2011
33,893,440 0 34,931,951
7,138,800 0 7,206,902
0 0 0

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.

US Code: 21 USC 351 Name of Law: null
  
None

Not associated with rulemaking

  75 FR 73101 11/29/2010
76 FR 6142 02/07/2011
No

1
IC Title Form No. Form Name
Current Good Manufacturing Practice Regulations for Medicated Feed, 21 CFR Part 225

  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 33,893,440 34,931,951 0 0 -1,038,511 0
Annual Time Burden (Hours) 7,138,800 7,206,902 0 0 -68,102 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$27,649
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/27/2011


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