Records and Reports Concerning Experience with Approved New Animal Drugs

Forms and Documents

Document Name	Status
Form Form FDA 1932 Records and Reports Concerning Experience with Approved New Animal Drugs Form and Instruction	Modified
Form 2301 Reporting: Requirement for submitting Distributor statements - Form FDA 2301 Form and Instruction	New
Form 2301 Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 Form and Instruction	New
Form 2301 Reporting: six Month Periodic Drug experience report ( Submit Annually After First 2 Years) Form FDA 2301 Form and Instruction	New
Form 1932a Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a Form and Instruction	New
SS-0910-0284 #3.doc Supporting Statement A	2011-10-20

IC Document Collections

IC ID	Document Title	Status
37624	Records and Reports Concerning Experience with Approved New Animal Drugs Form and Instruction	Modified
197284	Recordkeeping: Maintainence of Records ( data) by Applicants & Non Applicants That Was Not Submitted as Part of the NADA Application	New
197283	Reporting: Requirement for submitting Distributor statements - Form FDA 2301 Form and Instruction	New
197282	Reporting: Requirement for Submitting Advertisement & Promotional Material - Form FDA 2301	New
197281	Reporting: Requirement for Submission of Special Drug Experience Report More Frequently - Form FDA 2301 Form and Instruction	New
197280	Reporting: six Month Periodic Drug experience report ( Submit Annually After First 2 Years) Form FDA 2301 Form and Instruction	New
197279	Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a Form and Instruction	New

ICR Details

OMB Control No: 0910-0284	ICR Reference No: 201104-0910-005
Status: Historical Active	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 without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/12/2011
	Date Received in OIRA: 04/12/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	36 Months From Approved
Responses	26,969	0	0
Time Burden (Hours)	111,776	0	0
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 21 USC 512(I) Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
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
Reporting: Requirement for submitting Distributor statements - Form FDA 2301	2301	Transmittal of Periodic reports and Promotional Material
Recordkeeping: Maintainence of Records ( data) by Applicants & Non Applicants That Was Not Submitted as Part of the NADA Application
Reporting: Adverse Drug Experience & Product / Manufacturing Defects Voluntary reporting Using Form FDa 1932a	1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness
Reporting: six Month Periodic Drug experience report ( Submit Annually After First 2 Years) Form FDA 2301	2301	Transmittal of Periodic Reports and Promotional Material
Records and Reports Concerning Experience with Approved New Animal Drugs	Form FDA 1932	Veterinary Adverse Drug Reaction; Lack of Effectiveness or Product Defect Report

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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	26,969	0	0	0	-16,549	43,518
Annual Time Burden (Hours)	111,776	0	0	0	28,221	83,555
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:

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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

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Common Form ICR:  No

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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: 04/12/2011

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