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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:
0910-0284
ICR Reference No:
201412-0910-009
Status:
Historical Active
Previous ICR Reference No:
201104-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Records and Reports Concerning Experience with Approved New Animal Drugs
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
02/06/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/16/2014
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2018
36 Months From Approved
02/28/2015
Responses
12,410
0
26,969
Time Burden (Hours)
101,365
0
111,776
Cost Burden (Dollars)
0
0
0
Abstract:
The continuous monitoring of approved New Animal Drug Applications affords the primary means by which FDA obtains information regarding potential problems in safety and effectiveness of marketed animal drugs and potential manufacturing problems. Adverse reaction reports are required to be submitted by the drug manufacturer on FDA forms 1932 and 1932a( voluntary reporting form), following complaints from animal owners or veterinarians . Also product defects and lack of effectiveness complaints are submitted to FDA by the drug manufacturer following their own detection of a problem or complaints from product users or their veterinarians using forms FDA 1932 and 1932a. Form 2301 is used to submit the required transmittal reports and promotional material for new animal drugs.
Authorizing Statute(s):
US Code:
21 USC 512(I)
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:
79 FR 58355
09/29/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 74728
12/16/2014
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Recordkeeping: Maintainence of Records ( data) by Applicants & Non Applicants That Was Not Submitted as Part of the NADA Application
Records and Reports Concerning Experience with Approved New Animal Drugs
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a
1932a
Veterinary Adverse Drug Reaction, Lack of Effectiveness
Reporting: Annual drug experience report Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material
Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material
Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material forNew Animal Drugs
Reporting: Requirement for submitting Distributor statements - Form FDA 2301
2301
Transmittal of Periodic reports and Promotional Material
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
12,410
26,969
0
0
-14,559
0
Annual Time Burden (Hours)
101,365
111,776
0
2
-10,413
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Burden adjustment reflect revisions based on previous 3 years of reporting. This is explained more fully in the agency's supporting statement at Q15.
Annual Cost to Federal Government:
$700,000
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:
12/16/2014
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