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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:
201001-0910-012
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:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Improperly submitted and continue
Conclusion Date:
03/29/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/29/2010
Terms of Clearance:
This collection has been improperly submitted under the terms set out by 5 CFR 1320. The collection is incorrectly listed as an extension when it includes discretionary changes that impact the burden. Please resubmit this collection as a revision.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2010
36 Months From Approved
03/31/2010
Responses
43,518
0
43,518
Time Burden (Hours)
83,555
0
83,555
Cost Burden (Dollars)
0
0
0
Abstract:
Section 512 (l) of the Federal Food, Drug and Cosmetic Act (the act)(21 U.S.C.360b(l)and section 514.80 (21 CFR 514.80) of FDA regulations, require applicants of approved new animal drug applications (NADAs) and abbeviated new animal drug applications ( ANADAs) to report adverse drug experiences and product / manufactuing defects. This continuous monitoring of approved NADAs and ANADAs affords the primary means by which FDA obtains information regarding potential problems with the safety and effacy of marketed approved new animal drugs as well as potential product / manufacturing problems.
Authorizing Statute(s):
None
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 52967
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 Reporting Using FDA Form 1932
Form FDA 1932
Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report
AdverseDrug Experiences & Product /Manufacturing Defects Voluntary Reporting Using Form FDA 1932a
1932a
Veteinay Adverse Drug Reaction Lack of Effectiveness
Requirement for Applicants & NonApplicants to Establish and Maintain Records & files of New Animal Drug Data That Had Not Been Submitted As Part of the Application
Requirements for Submission of Special Drug Experience Reports More Frequently - Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material
Requirements for Submitting Advetisement & Promotional Labeling- Form FDA 2301
2301
Tansmittal of Periodic Reports and Promotional Material
Requirements for Submitting Distributor Statements- Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material
Six Month Periodic Drug Experience Report ( submit annually after first 2 years)- Paper Form FDA 2301
2301
Transmittal of Periodic Reports and Promotional Material
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
In response to comments received for the 60 day Federal register notice that published May 19,2006,(71 FR 29157 ), FDA made an adjustment for its reporting and recordkeeping burden estimates. The reporting estimate increased from 34,827 hours to 40,957 hours and the recordkeeping burden estimate increased from 34,316 hours to 43,013 hours (Refer to 30 day Federal Register notice; September 22,2006 (71 FR 55484)
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
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:
Jonnalynn Capezzuto 3018274659
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:
01/29/2010
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