Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

ICR 200411-0910-006

OMB: 0910-0154

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
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ICR Details
0910-0154 200411-0910-006
Historical Active 200107-0910-006
HHS/FDA
Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226
Extension without change of a currently approved collection   No
Regular
Approved without change 12/21/2004
Retrieve Notice of Action (NOA) 11/17/2004
  Inventory as of this Action Requested Previously Approved
12/31/2007 12/31/2007 12/31/2004
180,550 0 180,550
157,550 0 187,450
0 0 0

Type A Medicated Articles contain a new animal drug with or without carriers. It is intended for dilution into medicated feeds for administration to animals. Compliance with good manufacturing practice regulations assures that the Type A medicated article will be safe and effective when mixed into a medicated feed. Maintenance of records if required.

None
None


No

1
IC Title Form No. Form Name
Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

  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 180,550 180,550 0 0 0 0
Annual Time Burden (Hours) 157,550 187,450 0 0 -29,900 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
11/17/2004


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