View Information Collection Request (ICR) Package
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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:
201004-0910-009
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Abbreviated New Animal Drug Applications
Type of Information Collection:
Existing collection in use without an OMB Control Number
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/11/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/30/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2013
36 Months From Approved
Responses
42
0
0
Time Burden (Hours)
3,498
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
On November 16,1998, the President signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA) Public Law 100-670). Under Section 512 (n)(1) of the Federal Food, Drug and Cosmetic Act (the act)as amended by GADPTRA, any person may file an abbreviated new animal drug application (ANADA)seekinf approval of a generic copy of an approved new animal drug. Among other things, an ANADA is 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 abbreviated application.FDA permits applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review followed by the submission of an administrative ANADA when FDA finds that all the technical sections for an ANADA are complete.Form FDA 356V must be filled out and accompamy each request.
Authorizing Statute(s):
US Code:
21 USC 360b(b)(2)
Citations for New Statutory Requirements:
US Code: 21 USC 360b(b)(2)
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:
74 FR 56643
11/02/2009
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 12759
03/17/2010
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
356v
Application for Approval of a New Animal Drug ( or Submission to Support New Animal Drug Approval)
FD&C Act/ Section 512(n)(1) - Submission of a " Complete" ANADA by an Applicant
356v
Application for Approval of A New Animal Drug ( or Submission to Support New Animal Drug Approval.)
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
42
0
42
0
0
0
Annual Time Burden (Hours)
3,498
0
3,498
0
0
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:
This is a new information collection.
Annual Cost to Federal Government:
$2,476,203
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:
Denver Presley 3018271462
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:
04/30/2010
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