Abbreviated New Animal Drug Applications

ICR 201608-0910-009

OMB: 0910-0669

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2016-08-16
IC Document Collections
ICR Details
0910-0669 201608-0910-009
Historical Active 201309-0910-007
HHS/FDA CVM
Abbreviated New Animal Drug Applications
Extension without change of a currently approved collection   No
Regular
Approved without change 10/14/2016
Retrieve Notice of Action (NOA) 09/07/2016
  Inventory as of this Action Requested Previously Approved
10/31/2019 36 Months From Approved 10/31/2016
33 0 33
3,339 0 3,339
0 0 0

This ICR collects information from animal drug manufacturers who seek approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an abbreviated new animal drug application (ANADA) is described in section 512(n)(1) of the FD&C Act (21 U.S.C. 360b(n)(1)). Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. We allow applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review. We have developed Form FDA 356v to facilitate a complete ANADA or a phased review submission to ensure efficient and accurate processing of information.

US Code: 21 USC 360b(b)(2) Name of Law: FD&C Act
  
None

Not associated with rulemaking

  81 FR 29273 05/11/2016
81 FR 60705 09/02/2016
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 33 0 0 0 0
Annual Time Burden (Hours) 3,339 3,339 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$2,248,206
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
09/07/2016


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