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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0669
ICR Reference No:
201309-0910-007
Status:
Historical Active
Previous ICR Reference No:
201004-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
20483
Title:
Abbreviated New Animal Drug Applications
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/23/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/17/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2016
36 Months From Approved
10/31/2013
Responses
33
0
42
Time Burden (Hours)
3,339
0
3,498
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
US Code:
21 USC 360b(b)(2)
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 25279
04/30/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 52772
08/26/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
FD&C ACT/ Section 512(n)(1) - Phased Review Submission with Administrative ANADA
FDA 356v
Application for Approval of a New Animal Drug
FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant
FDA 356v
Application for Approval of a New Animal Drug
ICR Summary of Burden
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
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Extension of a currently approved collection.
Annual Cost to Federal Government:
$2,203,707
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
09/17/2013
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