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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:
201004-0910-008
Status:
Historical Inactive
Previous ICR Reference No:
200610-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Records and Reports Concerning Experience with Approved New Animal Drugs
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Withdrawn
Conclusion Date:
12/20/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/28/2010
Terms of Clearance:
In accordance with 5 CFR 1320, OMB is withdrawing this collection at the request of FDA.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
Section 512(I) of the Federal Food, Drug and Cosmetic Act( the act)(21 U.S.C. 360b(1)) and section 514.80( 21 CFR 514.80)of FDA regulations require applicants of approved new animal drug applications ( NADAs) and abbreviated new animal drug applications ( ANADAs)to report adverse drug experience and product / manufacturing defects. This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains information regarding potential problems with the satety and efficacy of marketed approved new animal drugs as well as potential product / manufacturing problems.
Authorizing Statute(s):
US Code:
21 USC 360b(1)
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:
74 FR 5267
10/15/2009
30-day Notice:
Federal Register Citation:
Citation Date:
75 FR 2865
01/19/2010
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Adverse Drug Experiences & Product / Manufacturing Defects Voluntary Reporting Using Form FDA 1932a
1932 A
Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Adverse Drug Experiences & Product / Manufacturing Defects Reporting Using FDA Form 1932
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
Requirement for Applicant & Non Applicant to Establish and Maintain Records & Files of New Animal Drug Data That Had Not Been Submitted As Part of The NADA Application
Requirement for Submission of Special Drug Experience Reports More Frequently Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submitting Advertisement & Promotional Labeling- Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Requirement for Submitting Distributor Statements - Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
Six Month Periodic Drug Experience Report( Submit annually after the first 2 years) Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material for New Animal Drugs
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The reporting and recordkeeping burdens for section 514.80 have increased. The increase in burden for submission of adverse drug ereactions on Form FDA 1932 results from greater awareness of the need for veterinarians and consumers to submit this information to the drug manufacturers as well as new approvals.While there is an increase in the estimated burden, the corresponding added information generated by the additional submissions greatly enhances FDAs ability to assess safety and edffectiveness of marketed drugs.
Annual Cost to Federal Government:
$1,079,363
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:
04/28/2010
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