New Animal Drugs for Investigational Use

ICR 201207-0910-001

OMB: 0910-0117

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2012-06-29
ICR Details
0910-0117 201207-0910-001
Historical Active 200806-0910-005
HHS/FDA
New Animal Drugs for Investigational Use
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 10/22/2012
Retrieve Notice of Action (NOA) 07/05/2012
  Inventory as of this Action Requested Previously Approved
10/31/2015 36 Months From Approved
5,528 0 0
12,328 0 0
0 0 0

To gain approval to market an animal drug, the applicant must file a New Animal Drug Application containing data to support the safety and effectiveness of the drug, appropriate labeling, product manufacturing information and where applicable, methods to determine residues of the drug in edible tissue from food producing animals.

US Code: 21 USC 512j Name of Law: null
  
None

Not associated with rulemaking

  76 FR 37814 06/28/2011
76 FR 59140 09/23/2011
No

  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 5,528 0 0 0 5,524 4
Annual Time Burden (Hours) 12,328 0 0 0 -11,477 23,805
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$472,257,000
No
No
No
No
No
Uncollected
Denver Presley 3018271462

  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.
07/05/2012


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