Abbreviated New Animal Drug Applications

ICR 201309-0910-007

OMB: 0910-0669

Federal Form Document

ICR Details
0910-0669 201309-0910-007
Historical Active 201004-0910-009
HHS/FDA 20483
Abbreviated New Animal Drug Applications
Extension without change of a currently approved collection   No
Regular
Approved without change 10/23/2013
Retrieve Notice of Action (NOA) 09/17/2013
  Inventory as of this Action Requested Previously Approved
10/31/2016 36 Months From Approved 10/31/2013
33 0 42
3,339 0 3,498
0 0 0

Respondents to this information collection are sponsors of abbreviated animal drug applications (ANADA) seeking approval of a generic copy of an approved new animal drug. These applications are required to contain information to demonstrate that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved drug referenced in the application. Form FDA 356V must also be completed and accompamy each submission.

US Code: 21 USC 360b(b)(2) Name of Law: null
  
None

Not associated with rulemaking

  78 FR 25279 04/30/2013
78 FR 52772 08/26/2013
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 33 42 0 0 -9 0
Annual Time Burden (Hours) 3,339 3,498 0 0 -159 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Extension of a currently approved collection.

$2,203,707
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
09/17/2013


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